Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01616693
Status:
COMPLETED
Last Update Posted:
2018-12-26
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'D011055', 'term': 'Poliovirus Vaccine, Oral'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D023321', 'term': 'Poliovirus Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeflores@path.org', 'phone': '(202) 822-0033', 'title': 'Jorge Flores', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'from first day of study to 4 weeks after last dose (11 weeks)', 'description': 'Field workers documented information on severe adverse events (SAEs) through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital.\n\nAdverse events solicited included: diarrhea, vomiting, reported fever, cough, and cold/runny nose. Any other adverse event that was not considered an SAE was documented as "any other illness".', 'eventGroups': [{'id': 'EG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 149, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 152, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 148, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 146, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 108}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 100}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 128}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 130}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold/runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 148}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 140}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 144}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Any other illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute febrile illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 155, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '280', 'groupId': 'OG004'}, {'value': '271', 'groupId': 'OG005'}, {'value': '273', 'groupId': 'OG006'}, {'value': '278', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG004', 'title': 'Zinc', 'description': 'All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)'}, {'id': 'OG005', 'title': 'No Zinc', 'description': 'All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)'}, {'id': 'OG006', 'title': 'Probiotic', 'description': 'All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)'}, {'id': 'OG007', 'title': 'No Probiotic', 'description': 'All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)'}], 'classes': [{'categories': [{'title': 'Seroconversion', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '96', 'groupId': 'OG006'}, {'value': '77', 'groupId': 'OG007'}]}, {'title': 'No seroconversion', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '186', 'groupId': 'OG004'}, {'value': '192', 'groupId': 'OG005'}, {'value': '177', 'groupId': 'OG006'}, {'value': '201', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005'], 'paramType': 'Difference in seroconversion proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '4.4', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '13.2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Difference in seroconversion proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '16.2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in seroconversion proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '.8', 'ciUpperLimit': '22.8', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine', 'description': 'Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (IgA) antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age.\n\nPre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Rotavirus-specific IgA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '280', 'groupId': 'OG004'}, {'value': '271', 'groupId': 'OG005'}, {'value': '273', 'groupId': 'OG006'}, {'value': '278', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG004', 'title': 'Zinc', 'description': 'All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)'}, {'id': 'OG005', 'title': 'No Zinc', 'description': 'All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)'}, {'id': 'OG006', 'title': 'Probiotic', 'description': 'All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)'}, {'id': 'OG007', 'title': 'No Probiotic', 'description': 'All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)'}], 'classes': [{'title': 'Pre-vaccination', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '11.6'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '13.9'}, {'value': '11.3', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '14.2'}, {'value': '12.2', 'groupId': 'OG003', 'lowerLimit': '9.5', 'upperLimit': '15.7'}, {'value': '10.0', 'groupId': 'OG004', 'lowerLimit': '8.5', 'upperLimit': '11.8'}, {'value': '11.7', 'groupId': 'OG005', 'lowerLimit': '9.9', 'upperLimit': '13.9'}, {'value': '10.2', 'groupId': 'OG006', 'lowerLimit': '8.7', 'upperLimit': '12.0'}, {'value': '11.5', 'groupId': 'OG007', 'lowerLimit': '9.6', 'upperLimit': '13.7'}]}]}, {'title': 'Post-vaccination', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '31.3'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '32.1'}, {'value': '25.4', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '33.6'}, {'value': '26.0', 'groupId': 'OG003', 'lowerLimit': '19.3', 'upperLimit': '34.9'}, {'value': '23.7', 'groupId': 'OG004', 'lowerLimit': '19.3', 'upperLimit': '29.1'}, {'value': '25.7', 'groupId': 'OG005', 'lowerLimit': '21.0', 'upperLimit': '31.4'}, {'value': '24.4', 'groupId': 'OG006', 'lowerLimit': '19.9', 'upperLimit': '29.8'}, {'value': '24.9', 'groupId': 'OG007', 'lowerLimit': '20.3', 'upperLimit': '30.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine', 'description': 'Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age).\n\nPre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '280', 'groupId': 'OG004'}, {'value': '271', 'groupId': 'OG005'}, {'value': '273', 'groupId': 'OG006'}, {'value': '278', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG004', 'title': 'Zinc', 'description': 'All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)'}, {'id': 'OG005', 'title': 'No Zinc', 'description': 'All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)'}, {'id': 'OG006', 'title': 'Probiotic', 'description': 'All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)'}, {'id': 'OG007', 'title': 'No Probiotic', 'description': 'All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)'}], 'classes': [{'categories': [{'title': 'Seroconversion', 'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}, {'value': '249', 'groupId': 'OG004'}, {'value': '238', 'groupId': 'OG005'}, {'value': '237', 'groupId': 'OG006'}, {'value': '250', 'groupId': 'OG007'}]}, {'title': 'No seroconversion', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '6.6', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '2.3', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '5.7', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from first dose of OPV to 4 weeks after last dose of OPV', 'description': 'A serologic immune response to OPV is defined as a neutralizing antibody titer to polio virus subtype 3 greater than or equal to 1:8 at 14 weeks of age. This antigen will be used as a conservative estimate because it gives the lowest immune response of all three polio antigens.\n\nPre-vaccination blood samples were taken when the subject received the first dose of OPV vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of OPV was administered (14 weeks of age).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}, {'value': '240', 'groupId': 'OG004'}, {'value': '234', 'groupId': 'OG005'}, {'value': '235', 'groupId': 'OG006'}, {'value': '239', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG004', 'title': 'Zinc', 'description': 'All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)'}, {'id': 'OG005', 'title': 'No Zinc', 'description': 'All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)'}, {'id': 'OG006', 'title': 'Probiotic', 'description': 'All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)'}, {'id': 'OG007', 'title': 'No Probiotic', 'description': 'All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)'}], 'classes': [{'categories': [{'title': 'Shedding 4 or 7 days post-vaccination', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}, {'title': 'No shedding 4 or 7 days post-vaccination', 'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '238', 'groupId': 'OG004'}, {'value': '231', 'groupId': 'OG005'}, {'value': '233', 'groupId': 'OG006'}, {'value': '236', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0, 4 and/or 7 day post dose 1 of rotavirus vaccine', 'description': 'Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by Real-time polymerase chain reaction (RT-PCR). Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received the vaccination on schedule and had valid stool samples on the days of testing.'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}, {'value': '132', 'groupId': 'OG005'}, {'value': '132', 'groupId': 'OG006'}, {'value': '136', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG004', 'title': 'Zinc', 'description': 'All subjects receiving zinc supplementation (zinc and probiotic; zinc and probiotic placebo groups)'}, {'id': 'OG005', 'title': 'No Zinc', 'description': 'All subjects receiving zinc placebo (group receiving zinc placebo and probiotic, combined with group receiving zinc placebo and probiotic placebo)'}, {'id': 'OG006', 'title': 'Probiotic', 'description': 'All subjects receiving probiotic supplementation (zinc and probiotic; zinc placebo and probiotic)'}, {'id': 'OG007', 'title': 'No Probiotic', 'description': 'All subjects receiving probiotic placebo (zinc and probiotic placebo; zinc placebo and probiotic placebo)'}], 'classes': [{'categories': [{'title': 'Shedding 4 or 7 days post-vaccination', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'No shedding 4 or 7 days post-vaccination', 'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}, {'value': '132', 'groupId': 'OG005'}, {'value': '132', 'groupId': 'OG006'}, {'value': '136', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0, 4 and/or 7 day post dose 2 of rotavirus vaccine', 'description': 'Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR. Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received the vaccination on schedule and had valid stool samples on the days of testing.'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}], 'classes': [{'categories': [{'title': 'Unrelated SAEs', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Related SAEs', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No SAEs', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from first day of study to 4 weeks after last dose', 'description': 'Field workers documented information on SAEs through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. All SAEs occurring at any time during the study were recorded on a SAE Form and were reviewed and evaluated by a study clinician and the local IRB. The relationship of the SAE to study vaccine was evaluated and recorded and reported to the local institutional review board (IRB). All SAEs were followed until satisfactory resolution.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'FG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'FG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}], 'periods': [{'title': 'Evaluated for Safety', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '154'}, {'groupId': 'FG003', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Received Both Vaccines', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '154'}, {'groupId': 'FG003', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '142'}, {'groupId': 'FG003', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}, {'title': 'Blood Analyzed for Immunogenicity', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '142'}, {'groupId': 'FG003', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '136'}, {'groupId': 'FG003', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Potential participants for this study lived in the area surrounding the Christian Medical College (CMC) in the town of Vellore, Tamil Nadu, India. Parents were contacted through the existing Demographic Surveillance System shortly after the child's birth. Procedures were conducted in the Chinallapuram Field Clinic."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}, {'value': '620', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Zinc and Probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'BG001', 'title': 'Zinc Alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nZinc: Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'BG002', 'title': 'Probiotic Alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic: A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.\n\nProbiotic placebo: The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no LGG. The contents of the capsule were given once daily orally.\n\nZinc placebo: The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.\n\nRotavirus vaccine: 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.\n\nOral polio vaccine: A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '.3', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '.3', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '.3', 'groupId': 'BG002'}, {'value': '5.2', 'spread': '.3', 'groupId': 'BG003'}, {'value': '5.1', 'spread': '.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '326', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '294', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}, {'value': '620', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Religion', 'classes': [{'categories': [{'title': 'Hindu', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '415', 'groupId': 'BG004'}]}, {'title': 'Christian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Muslim', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '179', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of house', 'classes': [{'categories': [{'title': 'Permanent (pucca)', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '360', 'groupId': 'BG004'}]}, {'title': 'Mixed', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}, {'title': 'Temporary', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 620}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2012-06-06', 'resultsFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2012-06-08', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-23', 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine', 'timeFrame': 'from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine', 'description': 'Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (IgA) antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age.\n\nPre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).'}, {'measure': 'Geometric Mean Concentration of Rotavirus-specific IgA', 'timeFrame': 'from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine', 'description': 'Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age).\n\nPre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).'}], 'secondaryOutcomes': [{'measure': 'Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)', 'timeFrame': 'from first dose of OPV to 4 weeks after last dose of OPV', 'description': 'A serologic immune response to OPV is defined as a neutralizing antibody titer to polio virus subtype 3 greater than or equal to 1:8 at 14 weeks of age. This antigen will be used as a conservative estimate because it gives the lowest immune response of all three polio antigens.\n\nPre-vaccination blood samples were taken when the subject received the first dose of OPV vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of OPV was administered (14 weeks of age).'}, {'measure': 'Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1', 'timeFrame': '0, 4 and/or 7 day post dose 1 of rotavirus vaccine', 'description': 'Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by Real-time polymerase chain reaction (RT-PCR). Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.'}, {'measure': 'Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2', 'timeFrame': '0, 4 and/or 7 day post dose 2 of rotavirus vaccine', 'description': 'Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR. Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.'}, {'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': 'from first day of study to 4 weeks after last dose', 'description': 'Field workers documented information on SAEs through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. All SAEs occurring at any time during the study were recorded on a SAE Form and were reviewed and evaluated by a study clinician and the local IRB. The relationship of the SAE to study vaccine was evaluated and recorded and reported to the local institutional review board (IRB). All SAEs were followed until satisfactory resolution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rotavirus', 'polio', 'zinc supplement', 'probiotic supplement', 'rotavirus vaccine shedding'], 'conditions': ['Immunity to Oral Rotavirus Vaccine', 'Immunity to Oral Polio Vaccine', 'Shedding of Oral Rotavirus Vaccine']}, 'descriptionModule': {'briefSummary': 'Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.\n\nThis study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.', 'detailedDescription': 'Co- Primary objectives:\n\n1. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus immunoglobulin A (IgA) antibodies) among Indian infants receiving zinc supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc placebo.\n2. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus IgA antibodies) among Indian infants receiving probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a probiotic placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Weeks', 'minimumAge': '5 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants 35-41 days old\n* Live in area under surveillance\n* Current weight ≥3.2 kg\n* No syndromic evidence of immunocompromise as determined by medical doctor\n* No prior illness requiring hospitalization\n* No current medical condition as determined by medical doctor which precludes study involvement\n* Available for follow up for duration of study (through approximately 14 weeks of age)\n* Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent\n\nExclusion Criteria:\n\n* Child has history of atopic symptoms\n* Child has a known digestive system defect\n* Child has history of chronic diarrhea\n* Child has major congenital anomalies\n* Child has received a prior dose of rotavirus vaccine\n* Child has received a prior dose of polio vaccine (beyond the birth dose)'}, 'identificationModule': {'nctId': 'NCT01616693', 'briefTitle': 'Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants', 'orgStudyIdInfo': {'id': 'CMC ZP 2012; PATH HS-658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc and probiotic', 'description': 'Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.', 'interventionNames': ['Dietary Supplement: Probiotic', 'Dietary Supplement: Zinc', 'Biological: Rotavirus vaccine', 'Biological: Oral polio vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zinc alone', 'description': 'Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.', 'interventionNames': ['Dietary Supplement: Zinc', 'Dietary Supplement: Probiotic placebo', 'Biological: Rotavirus vaccine', 'Biological: Oral polio vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic alone', 'description': 'Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.', 'interventionNames': ['Dietary Supplement: Probiotic', 'Dietary Supplement: Zinc placebo', 'Biological: Rotavirus vaccine', 'Biological: Oral polio vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.', 'interventionNames': ['Dietary Supplement: Probiotic placebo', 'Dietary Supplement: Zinc placebo', 'Biological: Rotavirus vaccine', 'Biological: Oral polio vaccine']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Culturelle'], 'description': 'A capsule that contains at least 1 x 10\\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.', 'armGroupLabels': ['Probiotic alone', 'Zinc and probiotic']}, {'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.', 'armGroupLabels': ['Zinc alone', 'Zinc and probiotic']}, {'name': 'Probiotic placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.', 'armGroupLabels': ['Placebo', 'Zinc alone']}, {'name': 'Zinc placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.', 'armGroupLabels': ['Placebo', 'Probiotic alone']}, {'name': 'Rotavirus vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Rotarix®'], 'description': '1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.', 'armGroupLabels': ['Placebo', 'Probiotic alone', 'Zinc alone', 'Zinc and probiotic']}, {'name': 'Oral polio vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Biopolio®'], 'description': 'A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.', 'armGroupLabels': ['Placebo', 'Probiotic alone', 'Zinc alone', 'Zinc and probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '632 004', 'city': 'Vellore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Christian Medical Center, Vellore', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}], 'overallOfficials': [{'name': 'Gagandeep Kang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christian Medical Center, Vellore, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Christian Medical College, Vellore, India', 'class': 'OTHER'}, {'name': 'Ministry of Science and Technology, India', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}