Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT01463293
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
B. Lactis HN019 for Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.dekker@fonterra.com', 'phone': '+64 6 350 6323', 'title': 'Dr James Dekker', 'organization': 'Fonterra Research Centre'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A substantial number of protocol violations occurred for the primary end-point. Only 39 out of 224 subjects consumed sufficent radio-opaque markers for baseline and post-intervention transit time.Therefore, the study failed to yield evaluable data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High-dose Probiotic', 'description': 'Capsule containing 10 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day', 'otherNumAtRisk': 74, 'otherNumAffected': 17, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose Probiotic', 'description': 'Capsule containing 1 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day', 'otherNumAtRisk': 79, 'otherNumAffected': 16, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo capsule\n\nPlacebo: Capsule containing no probiotic once a day', 'otherNumAtRisk': 71, 'otherNumAffected': 20, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Respriatory symptoms', 'notes': 'Upper respiratory tract infection, common cold, bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Whole Gut Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose Probiotic', 'description': 'Capsule containing 10 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day'}, {'id': 'OG001', 'title': 'Low Dose Probiotic', 'description': 'Capsule containing 1 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsule\n\nPlacebo: Capsule containing no probiotic once a day'}], 'timeFrame': '4 weeks', 'description': 'The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 39 out of the 224 enrolled subjects consumed the radio-opaque markers in line with the protocol. Because of the substantial number of protocol deviations and the lack of sufficient evaluable subjects, no further analyses of the study data were performed. The study appears not to have yielded evaluable data.'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of Constipation Symptoms (PAC-SYM)', 'timeFrame': '4 weeks', 'description': 'The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of Constipation QoL (PAC-QoL)', 'timeFrame': '4 weeks', 'description': 'The PAC-QoL is a 28-question survey that asks questions on their quality of life.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Bowel Function Index', 'timeFrame': '4 weeks', 'description': 'The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Adequate Relief of Constipation (Yes/no)', 'timeFrame': '4 weeks', 'description': 'Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Bowel Movement Frequency', 'timeFrame': '4 weeks', 'description': 'Subjects will record the number of defecations per day in a diary.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Consistency', 'timeFrame': '4 weeks', 'description': 'Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Product Satisfaction', 'timeFrame': '4 weeks', 'description': "At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Frequency', 'timeFrame': '4 weeks', 'description': 'All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-dose Probiotic', 'description': 'Capsule containing 10 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day'}, {'id': 'FG001', 'title': 'Low Dose Probiotic', 'description': 'Capsule containing 1 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo capsule\n\nPlacebo: Capsule containing no probiotic once a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High-dose Probiotic', 'description': 'Capsule containing 10 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day'}, {'id': 'BG001', 'title': 'Low Dose Probiotic', 'description': 'Capsule containing 1 billion cfu B. lactis HN019\n\nB. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo capsule\n\nPlacebo: Capsule containing no probiotic once a day'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '41.8', 'spread': '12.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian, non-Hispanic', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'African-American, Black', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height, M', 'classes': [{'categories': [{'measurements': [{'value': '1.66', 'spread': '0.12', 'groupId': 'BG000'}, {'value': '1.68', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '1.68', 'spread': '0.10', 'groupId': 'BG002'}, {'value': '1.68', 'spread': '0.10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'M', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight, Kg', 'classes': [{'categories': [{'measurements': [{'value': '74.9', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '77.5', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '74.3', 'spread': '14.9', 'groupId': 'BG002'}, {'value': '75.6', 'spread': '15.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '26.6', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '27.0', 'spread': '4.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2011-10-28', 'resultsFirstSubmitDate': '2014-06-26', 'studyFirstSubmitQcDate': '2011-10-31', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-26', 'studyFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole Gut Transit Time', 'timeFrame': '4 weeks', 'description': 'The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28'}], 'secondaryOutcomes': [{'measure': 'Patient Assessment of Constipation Symptoms (PAC-SYM)', 'timeFrame': '4 weeks', 'description': 'The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.'}, {'measure': 'Patient Assessment of Constipation QoL (PAC-QoL)', 'timeFrame': '4 weeks', 'description': 'The PAC-QoL is a 28-question survey that asks questions on their quality of life.'}, {'measure': 'Bowel Function Index', 'timeFrame': '4 weeks', 'description': 'The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.'}, {'measure': 'Adequate Relief of Constipation (Yes/no)', 'timeFrame': '4 weeks', 'description': 'Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.'}, {'measure': 'Bowel Movement Frequency', 'timeFrame': '4 weeks', 'description': 'Subjects will record the number of defecations per day in a diary.'}, {'measure': 'Stool Consistency', 'timeFrame': '4 weeks', 'description': 'Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form'}, {'measure': 'Overall Product Satisfaction', 'timeFrame': '4 weeks', 'description': "At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale"}, {'measure': 'Adverse Event Frequency', 'timeFrame': '4 weeks', 'description': 'All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['constipation', 'probiotic', 'functional constipation', 'IBS-C'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.', 'detailedDescription': 'This prospective, double-blind, randomized, placebo-controlled clinical trial will investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation. Participants who meet all study entry criteria will enter a 2-week run-in period. Following successful completion of the run-in period, subjects will be randomized to 4-week supplementation with B. lactis HN019 (10 billion cfu), B. lactis HN019 (1 billion cfu), or placebo. The primary outcome of whole gut transit time will be evaluated with abdominal x-rays on days 0 and 28. Secondary outcomes include IBS-specific questionnaires (administered on days 0 and 28); abdominal pain severity, bowel movement frequency, stool consistency, and adverse events (evaluated daily throughout the study); and overall product satisfaction (evaluated at day 28). Physical activity questionnaires and 24-hour food recalls will be completed periodically during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 70 years\n* Body mass index between 18.5 and 34.9 kg/m2\n* Self-reported unsatisfactory defecation due to infrequent stools and/or difficult stool passage, which includes at least one of the following: symptoms of straining, difficulty expelling stool, a sense of incomplete evacuation, hard or lumpy stools, prolonged time to stool, or a need for manual maneuvers to pass stool.\n* Estimated stool consistency \\< 4.0 on BSSF (self-reported at screening) within the past month prior to enrollment.\n* Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects\n* Consent to the study and willing to comply with study product and methods\n\nExclusion Criteria:\n\n* Major gastrointestinal complication (e.g. Crohn's disease, ulcer)\n* Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the subject or confound study results\n* Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)\n* Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products\n* Non-laxative constipation medication use within 2 weeks of screening, laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study)\n* Daily use of anticholinergic agents, opioid analgesics, calcium supplements, calcium-channel blockers, and NSAIDs\n* Anticipated major dietary or exercise changes during the study\n* Systemic steroid use\n* Eating disorder\n* Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product)\n* History of alcohol, drug, or medication abuse\n* Pregnant or lactating female, or pregnancy planned during study period\n* Participation in another study with any investigational product within 30 days of screening\n* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study"}, 'identificationModule': {'nctId': 'NCT01463293', 'acronym': 'CTT', 'briefTitle': 'B. Lactis HN019 for Functional Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fonterra Research Centre'}, 'officialTitle': 'Effects of 4-week Bifidobacterium Lactis HN019 Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial', 'orgStudyIdInfo': {'id': '11-SUS-02-FON-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose probiotic', 'description': 'Capsule containing 10 billion cfu B. lactis HN019', 'interventionNames': ['Dietary Supplement: B. lactis HN019']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose probiotic', 'description': 'Capsule containing 1 billion cfu B. lactis HN019', 'interventionNames': ['Dietary Supplement: B. lactis HN019']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'B. lactis HN019', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule containing 10 billion cfu B. lactis HN019 once a day', 'armGroupLabels': ['High-dose probiotic']}, {'name': 'B. lactis HN019', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule containing 1 billion cfu B. lactis HN019 once a day', 'armGroupLabels': ['Low dose probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule containing no probiotic once a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arrowhead Family Health Center', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Diagnamics, Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92840', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Digestive & Liver Disease Specialists', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'StayWell Research', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Sprim ALS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'facility': 'Westlake Medical Research', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '77054', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials South Main', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77450', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Village Health Partners', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Family Medicine', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Robert Hardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Digestive Care, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fonterra Research Centre', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'DuPont Nutrition and Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}