Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-25 @ 2:36 AM
Study NCT ID:
NCT02016820
Status:
TERMINATED
Last Update Posted:
2023-12-26
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Acid Suppression Medication on Pediatric Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D013535', 'term': 'Suspensions'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'def2004@cumc.columbia.edu', 'title': 'Daniel E. Freedberg, MD, MS', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '64 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Omeprazole (Suspension)', 'description': 'Open-label, with all subjects receiving omeprazole\n\nOmeprazole (suspension): 1 mg/kg/day', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lifestyle Modification', 'description': 'Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)\n\nLifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omeprazole (Suspension)', 'description': 'Open-label, with all subjects receiving omeprazole\n\nOmeprazole (suspension): 1 mg/kg/day'}, {'id': 'OG001', 'title': 'Lifestyle Modification', 'description': 'Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)\n\nLifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed'}], 'timeFrame': 'From week 12 to week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed as only 1 participant completed. Data was not analyzed and is not included here to protect the confidentiality of this one participant.'}, {'type': 'SECONDARY', 'title': 'Percent Subjects Eating High Fiber Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omeprazole (Suspension)', 'description': 'Open-label, with all subjects receiving omeprazole\n\nOmeprazole (suspension): 1 mg/kg/day'}, {'id': 'OG001', 'title': 'Lifestyle Modification', 'description': 'Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)\n\nLifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed'}], 'timeFrame': 'Up to Week 64', 'description': 'At each study visit, we will assess the effects of longterm diet on the microbiome by using the Harvard-Willett Food Frequency Questionnaire. Using this data, we will classify each subject as low vs high fiber.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed as only 1 participant completed. Data was not analyzed and is not included here to protect the confidentiality of this one participant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omeprazole (Suspension)', 'description': 'Open-label, with all subjects receiving omeprazole\n\nOmeprazole (suspension): 1 mg/kg/day'}, {'id': 'FG001', 'title': 'Lifestyle Modification', 'description': 'Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)\n\nLifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omeprazole (Suspension)', 'description': 'Open-label, with all subjects receiving omeprazole\n\nOmeprazole (suspension): 1 mg/kg/day'}, {'id': 'BG001', 'title': 'Lifestyle Modification', 'description': 'Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)\n\nLifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2013-12-16', 'resultsFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-05', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications', 'timeFrame': 'From week 12 to week 4'}], 'secondaryOutcomes': [{'measure': 'Percent Subjects Eating High Fiber Diet', 'timeFrame': 'Up to Week 64', 'description': 'At each study visit, we will assess the effects of longterm diet on the microbiome by using the Harvard-Willett Food Frequency Questionnaire. Using this data, we will classify each subject as low vs high fiber.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clostridium Difficile Infection', 'Proton Pump Inhibitors', 'Histamine-2 Receptor Antagonists', 'Gastroesophageal Reflux Disease'], 'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.', 'detailedDescription': 'Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Zero to 4 years old\n* Being considered for PPI or H2RA treatment for refractory GERD\n* Parent is able to give informed consent\n\nExclusion Criteria:\n\n* Prevalent C. difficile infection (excluded via stool PCR at week 0)\n* Use of systemic antibiotics within the past 90 days\n* Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)\n* Increased risk for fracture due to vitamin D deficiency or other causes\n* Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)\n* Congenital deficiency in immunity (e.g., such as IgA deficiency)\n* Cystic fibrosis\n* Significant dynamic or uncontrolled comorbidity such as HIV or malignancy\n* Use of medications with potential interaction with PPIs'}, 'identificationModule': {'nctId': 'NCT02016820', 'briefTitle': 'Effect of Acid Suppression Medication on Pediatric Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children', 'orgStudyIdInfo': {'id': 'AAAM9955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omeprazole (suspension)', 'description': 'Open-label, with all subjects receiving omeprazole', 'interventionNames': ['Drug: Omeprazole (suspension)']}, {'type': 'OTHER', 'label': 'Lifestyle Modification', 'description': 'Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)', 'interventionNames': ['Other: Lifestyle Modification']}], 'interventions': [{'name': 'Omeprazole (suspension)', 'type': 'DRUG', 'otherNames': ['As above'], 'description': '1 mg/kg/day', 'armGroupLabels': ['Omeprazole (suspension)']}, {'name': 'Lifestyle Modification', 'type': 'OTHER', 'description': 'Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed', 'armGroupLabels': ['Lifestyle Modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Julian S Abrams, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Daniel E Freedberg, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Epidemiology', 'investigatorFullName': 'Julian A Abrams, MD', 'investigatorAffiliation': 'Columbia University'}}}}