Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 11:47 PM
Study NCT ID:
NCT05141903
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dietary Supplement With and Without a Probiotic and/or Antibiotic
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drechtman@prolacta.com', 'phone': '8887765228', 'title': 'Dr. David Rechtman VP, Medical Affairs', 'organization': 'Prolacta Bioscience'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 7 weeks (D1 through D35)', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Antibiotics (Only)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Antibiotics, Probiotic, HMO Concentrate', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3', 'description': 'Antibiotics, Probiotic', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm 4', 'description': 'Antibiotics, Probiotic, HMO concentrate, Food Supplement', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Arm 5', 'description': 'Antibiotics, Probiotic, Food Supplement', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Hypermotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SARS-COV-2 Test Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (Only)'}, {'id': 'OG001', 'title': 'Antibiotics, Probiotics, HMO', 'description': 'Antibiotics, Probiotic, HMO Concentrate'}, {'id': 'OG002', 'title': 'Antibiotics Probiotics', 'description': 'Antibiotics and Probiotic'}, {'id': 'OG003', 'title': 'Antibiotics, Probiotics, HMO, Food', 'description': 'Antibiotics, Probiotic, HMO concentrate, Food Supplement'}, {'id': 'OG004', 'title': 'Antibiotics, Probiotics, Food', 'description': 'Antibiotics, Probiotic, Food Supplement'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '31.25', 'spread': '82.27', 'groupId': 'OG001'}, {'value': '27.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '27.00', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '27.00', 'spread': '0.00', 'groupId': 'OG004'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '27.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '383.41', 'spread': '862.67', 'groupId': 'OG001'}, {'value': '535.35', 'spread': '708.21', 'groupId': 'OG002'}, {'value': '204.11', 'spread': '312.05', 'groupId': 'OG003'}, {'value': '431.26', 'spread': '883.43', 'groupId': 'OG004'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '28.08', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '26877.59', 'spread': '69845.62', 'groupId': 'OG001'}, {'value': '1868.09', 'spread': '10150.73', 'groupId': 'OG002'}, {'value': '21736.64', 'spread': '50622.14', 'groupId': 'OG003'}, {'value': '45466.96', 'spread': '81975.89', 'groupId': 'OG004'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '27.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '311.22', 'spread': '14917.81', 'groupId': 'OG001'}, {'value': '77.15', 'spread': '1857.25', 'groupId': 'OG002'}, {'value': '88.78', 'spread': '1249.73', 'groupId': 'OG003'}, {'value': '170.03', 'spread': '5638.54', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '(Dose group \\* Time)', 'groupDescription': 'Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Dfn, Dfd = 11, 369 F Value = 24.31'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Dose group \\* Time', 'groupDescription': 'Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Dfn, Dfd = 11, 370 F value = 14.87'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Dose Group \\* Time', 'groupDescription': 'Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Dfn, Dfd = 11, 351 F value = 8.606'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day, 5, 14, 35', 'description': 'Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.', 'unitOfMeasure': 'copies/ng DNA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assigned to an arm and were able to provide adequate evaluable samples for DNA analysis'}, {'type': 'SECONDARY', 'title': 'Changes in Immune Markers Assessment at Day 5, 14 and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (only)'}, {'id': 'OG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'Antibiotics, probiotic, HMO concentrate'}], 'classes': [{'title': 'LAP-TGFB - baseline', 'categories': [{'measurements': [{'value': '34.3', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'LAP-TGFB - Day 5', 'categories': [{'measurements': [{'value': '34.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'LAP-TGFB - Day 14', 'categories': [{'measurements': [{'value': '29.7', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '34.7', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'LAP-TGFB - Day 28', 'categories': [{'measurements': [{'value': '30.2', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '32.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'MCP1 - Baseline', 'categories': [{'measurements': [{'value': '405.6', 'spread': '211.3', 'groupId': 'OG000'}, {'value': '399.7', 'spread': '253.3', 'groupId': 'OG001'}]}]}, {'title': 'MCP1 - Day 5', 'categories': [{'measurements': [{'value': '416.6', 'spread': '214.0', 'groupId': 'OG000'}, {'value': '401.8', 'spread': '215.5', 'groupId': 'OG001'}]}]}, {'title': 'MCP1 - Day 14', 'categories': [{'measurements': [{'value': '476.8', 'spread': '243.8', 'groupId': 'OG000'}, {'value': '411.1', 'spread': '199.1', 'groupId': 'OG001'}]}]}, {'title': 'MCP1 - Day 28', 'categories': [{'measurements': [{'value': '464.3', 'spread': '250.6', 'groupId': 'OG000'}, {'value': '433.8', 'spread': '187.3', 'groupId': 'OG001'}]}]}, {'title': 'MIP - Baseline', 'categories': [{'measurements': [{'value': '385.7', 'spread': '106.9', 'groupId': 'OG000'}, {'value': '358.2', 'spread': '228.7', 'groupId': 'OG001'}]}]}, {'title': 'MIP - Day 5', 'categories': [{'measurements': [{'value': '429', 'spread': '129.9', 'groupId': 'OG000'}, {'value': '391.9', 'spread': '231.0', 'groupId': 'OG001'}]}]}, {'title': 'MIP - Day 14', 'categories': [{'measurements': [{'value': '383.6', 'spread': '226.1', 'groupId': 'OG000'}, {'value': '361.6', 'spread': '224.2', 'groupId': 'OG001'}]}]}, {'title': 'MIP - Day 28', 'categories': [{'measurements': [{'value': '315.1', 'spread': '134.5', 'groupId': 'OG000'}, {'value': '322.0', 'spread': '226.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline-28 days', 'description': 'Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of Group 1 control vs Group 2 +HMO to assess impact of study product. Subjects who provided evaluable samples for all time points were evaluated for clinical pharmacology endpoints. DATA WERE COLLECTED FOR ONLY GROUPS 1 AND 2.'}, {'type': 'SECONDARY', 'title': 'Blood Pressures of Subjects From Baseline to Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (Only)'}, {'id': 'OG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'Antibiotics, Probiotic, HMO Concentrate'}, {'id': 'OG002', 'title': 'Antibiotics Probiotic', 'description': 'Antibiotics, Probiotic'}, {'id': 'OG003', 'title': 'Antibiotics, Probiotic, HMO, Food', 'description': 'Antibiotics, Probiotic, HMO concentrate, Food Supplement'}, {'id': 'OG004', 'title': 'Antibiotics, Probiotic, Food', 'description': 'Antibiotics, Probiotic, Food Supplement'}], 'classes': [{'title': 'Systolic Blood Pressure (mmHg) - Baseline', 'categories': [{'measurements': [{'value': '123', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '125', 'spread': '19', 'groupId': 'OG001'}, {'value': '127', 'spread': '15.2', 'groupId': 'OG002'}, {'value': '117', 'spread': '11', 'groupId': 'OG003'}, {'value': '121', 'spread': '15.6', 'groupId': 'OG004'}]}]}, {'title': 'Systolic Blood Pressure (mmHg) - Day 35', 'categories': [{'measurements': [{'value': '128', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '127', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '130', 'spread': '18.7', 'groupId': 'OG002'}, {'value': '121', 'spread': '14.8', 'groupId': 'OG003'}, {'value': '120', 'spread': '18.1', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg) - Baseline', 'categories': [{'measurements': [{'value': '75', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '77', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '76', 'spread': '9.7', 'groupId': 'OG002'}, {'value': '71', 'spread': '8.5', 'groupId': 'OG003'}, {'value': '73', 'spread': '7.9', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg) - Day 35', 'categories': [{'measurements': [{'value': '75', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '74', 'spread': '10', 'groupId': 'OG001'}, {'value': '77', 'spread': '12.1', 'groupId': 'OG002'}, {'value': '73', 'spread': '10', 'groupId': 'OG003'}, {'value': '71', 'spread': '10.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 - 35', 'description': 'Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \\[BP\\]). Descriptive statistics performed by dose group and visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assigned to an arm and were able to provide blood pressure data.'}, {'type': 'SECONDARY', 'title': 'Heart Rates of Subjects From Baseline to Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (Only)'}, {'id': 'OG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'Antibiotics, Probiotic, HMO Concentrate'}, {'id': 'OG002', 'title': 'Antibiotic, Probiotic', 'description': 'Antibiotics, probiotic'}, {'id': 'OG003', 'title': 'Antibiotics, Probiotic, HMO, Food', 'description': 'Antibiotics, probiotic, HMO concentrate, food supplement'}, {'id': 'OG004', 'title': 'Antibiotics, Probiotic, Food', 'description': 'Antibiotics, probiotic, food supplement'}], 'classes': [{'title': 'Heart rate - Baseline', 'categories': [{'measurements': [{'value': '66', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '66', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '68', 'spread': '8.1', 'groupId': 'OG002'}, {'value': '70', 'spread': '11.9', 'groupId': 'OG003'}, {'value': '71', 'spread': '7.4', 'groupId': 'OG004'}]}]}, {'title': 'Heart rate - Day 35', 'categories': [{'measurements': [{'value': '69', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '72', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '73', 'spread': '11.1', 'groupId': 'OG002'}, {'value': '66', 'spread': '11.9', 'groupId': 'OG003'}, {'value': '68', 'spread': '10.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0-35', 'description': 'Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assigned to an arm and were able to provide heart rate data.'}, {'type': 'SECONDARY', 'title': 'Respiratory Rates of Subjects From Baseline to Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (Only)'}, {'id': 'OG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'Antibiotics, Probiotic, HMO Concentrate'}, {'id': 'OG002', 'title': 'Antibiotic, Probiotic', 'description': 'Antibiotics, probiotic'}, {'id': 'OG003', 'title': 'Antibiotics, Probiotic, HMO, Food', 'description': 'Antibiotics, probiotic, HMO concentrate, food supplement'}, {'id': 'OG004', 'title': 'Antibiotics, Probiotic, Food', 'description': 'Antibiotics, probiotic, food supplement'}], 'classes': [{'title': 'Respirations - Baseline', 'categories': [{'measurements': [{'value': '15', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '15', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '15', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '15', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '16', 'spread': '1.2', 'groupId': 'OG004'}]}]}, {'title': 'Respirations - Day 35', 'categories': [{'measurements': [{'value': '15', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '15', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '15', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '15', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '14', 'spread': '0.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0-35', 'description': 'Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assigned to an arm and were able to provide respiration rates'}, {'type': 'SECONDARY', 'title': 'Temperatures of Subjects From Baseline to Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (Only)'}, {'id': 'OG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'Antibiotics, Probiotic, HMO Concentrate'}, {'id': 'OG002', 'title': 'Antibiotic, Probiotic', 'description': 'Antibiotics, probiotic'}, {'id': 'OG003', 'title': 'Antibiotics, Probiotic, HMO, Food', 'description': 'Antibiotics, probiotic, HMO concentrate, food supplement'}, {'id': 'OG004', 'title': 'Antibiotics, Probiotic, Food', 'description': 'Antibiotics, probiotic, food supplement'}], 'classes': [{'title': 'Temperature - Baseline', 'categories': [{'measurements': [{'value': '36.8', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '36.9', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '36.8', 'spread': '0.28', 'groupId': 'OG003'}, {'value': '36.9', 'spread': '0.22', 'groupId': 'OG004'}]}]}, {'title': 'Temperature - Day 35', 'categories': [{'measurements': [{'value': '36.9', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '36.8', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '36.8', 'spread': '0.28', 'groupId': 'OG003'}, {'value': '36.8', 'spread': '0.28', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0-35', 'description': 'Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).', 'unitOfMeasure': 'deg C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assigned to an arm and were able to provide temperatures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antibiotics Alone', 'description': 'Antibiotics (Only)'}, {'id': 'FG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'Antibiotics, Probiotic, HMO Concentrate'}, {'id': 'FG002', 'title': 'Antibiotics Probiotic', 'description': 'Antibiotics, Probiotic'}, {'id': 'FG003', 'title': 'Antibiotics, Probiotic, HMO, Food', 'description': 'Antibiotics, Probiotic, HMO concentrate, Food Supplement'}, {'id': 'FG004', 'title': 'Antibiotics, Probiotic, Food', 'description': 'Antibiotics, Probiotic, Food Supplement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '92', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Antibiotics Alone', 'description': 'D1-D5: Antibiotics (3x daily)\n\nAntibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)'}, {'id': 'BG001', 'title': 'Antibiotics, Probiotic, HMO', 'description': 'D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily)\n\nAntibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)\n\nHMO Concentrate: Concentrated milk fortifiers from donor human milk\n\nProbiotic: B. infantis'}, {'id': 'BG002', 'title': 'Antibiotics, Probiotic', 'description': 'D1-D5: Antibiotics (3x daily) D1-D14: Probiotic\n\nAntibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)\n\nProbiotic: B. infantis'}, {'id': 'BG003', 'title': 'Antibiotics, Probiotic, HMO, Food', 'description': "D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily)\n\nAntibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)\n\nHMO Concentrate: Concentrated milk fortifiers from donor human milk\n\nProbiotic: B. infantis\n\nFood Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)"}, {'id': 'BG004', 'title': 'Antibiotics, Probiotic, Food', 'description': "D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily)\n\nAntibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)\n\nProbiotic: B. infantis\n\nFood Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)"}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '92', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Levels of B. Infantis', 'classes': [{'categories': [{'measurements': [{'value': '27.00', 'spread': '0.00', 'groupId': 'BG000'}, {'value': '31.25', 'spread': '82.27', 'groupId': 'BG001'}, {'value': '27.00', 'spread': '0.00', 'groupId': 'BG002'}, {'value': '27.00', 'spread': '0.00', 'groupId': 'BG003'}, {'value': '27.00', 'spread': '0.00', 'groupId': 'BG004'}, {'value': '27.8', 'spread': '36.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'copies/ng DNA', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-22', 'size': 432792, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-14T13:12', 'hasProtocol': True}, {'date': '2023-06-15', 'size': 649266, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-14T13:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, Urine, and Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2021-11-19', 'resultsFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-13', 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)', 'timeFrame': 'Baseline, Day, 5, 14, 35', 'description': 'Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.'}], 'secondaryOutcomes': [{'measure': 'Changes in Immune Markers Assessment at Day 5, 14 and 28', 'timeFrame': 'Baseline-28 days', 'description': 'Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.'}, {'measure': 'Blood Pressures of Subjects From Baseline to Day 35', 'timeFrame': 'Day 0 - 35', 'description': 'Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \\[BP\\]). Descriptive statistics performed by dose group and visit.'}, {'measure': 'Heart Rates of Subjects From Baseline to Day 35', 'timeFrame': 'Day 0-35', 'description': 'Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.'}, {'measure': 'Respiratory Rates of Subjects From Baseline to Day 35', 'timeFrame': 'Day 0-35', 'description': 'Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.'}, {'measure': 'Temperatures of Subjects From Baseline to Day 35', 'timeFrame': 'Day 0-35', 'description': 'Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.', 'detailedDescription': 'The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers who have received antibiotics. The combination should support general gastrointestinal health.\n\nThis study is a multi-dose randomized cohort trial using 18 subjects per cohort for a total of 90 healthy adult volunteers ages 18-75.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Adults, ages 18-75.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults between the ages of 18-75 years (subjects must be 18-75 at the time of consent) who can provide proof of vaccination against SARS-CoV-2. Proof may be a physical or electronic record of vaccination or self-attestation (to include approximate vaccination date and manufacturer of vaccine) if a copy of the vaccination record is not available\n* Subjects must have a BMI of 18 - 30 at screening visit\n* Willingness to complete study specific questionnaires\n* Willingness to complete journal to record IP dosing times, Bristol stool scores, and IP flavor questionnaires\n* Willingness to complete all study procedures, clinic visits, and provide required biospecimen samples\n* Willingness to collect and process stool samples at home and transport stool samples to clinic\n* Sexually active females of child-bearing potential must agree to use highly effective methods of contraception during heterosexual intercourse throughout the study period and for three days following discontinuation of IP, whichever comes later. Examples of highly effective methods include the use of two forms of contraception with one being an effective barrier method (e.g., a condom and spermicide used together), or have a vasectomised partner. Abstinence is acceptable as a life-style choice. Female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing\n* Provide informed consent\n\nExclusion Criteria:\n\n* Subjects with a BMI of 17 or less or 31 or greater are excluded\n* Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study\n* Subjects who intend to take a probiotic during the study\n* Subjects with self-reported diarrhea on day 1 prior to dosing, whereby diarrhea is defined as two or more episodes of watery and/or unformed stool within 24 hours\n* Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening and day 1 of the study\n* Unstable medical condition, in the opinion of the investigator\n* Subject with a history of allergy to the study antibiotics\n* Clinically significant abnormal laboratory test results at screening\n* Subjects who are unable or unwilling to provide stool samples on a regular basis as per study protocol\n* Participation in a clinical research trial within 30 days prior to screening\n* Unable to give informed consent\n* Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject\n* Known carriers of C. difficile prior to study start, as determined by qPCR of stool\n* Known carriers of vancomycin-resistant enterococci (VRE) prior to study start, as determined by stool culture\n* Subjects with history of lactose intolerance"}, 'identificationModule': {'nctId': 'NCT05141903', 'briefTitle': 'Dietary Supplement With and Without a Probiotic and/or Antibiotic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prolacta Bioscience'}, 'officialTitle': 'Dietary Study of a Complex Oligosaccharide With and Without a Probiotic Following Antibiotic Treatment in Healthy Volunteers', 'orgStudyIdInfo': {'id': '21-CT-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'D1-D5: Antibiotics (3x daily)', 'interventionNames': ['Dietary Supplement: Antibiotic']}, {'label': 'Arm 2', 'description': 'D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily)', 'interventionNames': ['Dietary Supplement: Antibiotic', 'Dietary Supplement: HMO Concentrate', 'Dietary Supplement: Probiotic']}, {'label': 'Arm 3', 'description': 'D1-D5: Antibiotics (3x daily) D1-D14: Probiotic', 'interventionNames': ['Dietary Supplement: Antibiotic', 'Dietary Supplement: Probiotic']}, {'label': 'Arm 4', 'description': 'D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily)', 'interventionNames': ['Dietary Supplement: Antibiotic', 'Dietary Supplement: HMO Concentrate', 'Dietary Supplement: Probiotic', 'Dietary Supplement: Food Supplement']}, {'label': 'Arm 5', 'description': 'D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily)', 'interventionNames': ['Dietary Supplement: Antibiotic', 'Dietary Supplement: Probiotic', 'Dietary Supplement: Food Supplement']}], 'interventions': [{'name': 'Antibiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5']}, {'name': 'HMO Concentrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Concentrated milk fortifiers from donor human milk', 'armGroupLabels': ['Arm 2', 'Arm 4']}, {'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'B. infantis', 'armGroupLabels': ['Arm 2', 'Arm 3', 'Arm 4', 'Arm 5']}, {'name': 'Food Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': "Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)", 'armGroupLabels': ['Arm 4', 'Arm 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Altasciences', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prolacta Bioscience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}