Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 7:09 AM
Study NCT ID:
NCT02359604
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2014-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'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': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Longitudinal study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2014-10-31', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities', 'timeFrame': '16 weeks', 'description': 'The change of intestinal microbiota under PPI therapy will be examined.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infant', 'ppi', 'proton pump inhibitor', 'microbiome', 'Microbiota'], 'conditions': ['Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '29075620', 'type': 'DERIVED', 'citation': 'Castellani C, Singer G, Kashofer K, Huber-Zeyringer A, Flucher C, Kaiser M, Till H. The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study. Front Cell Infect Microbiol. 2017 Oct 11;7:444. doi: 10.3389/fcimb.2017.00444. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce.\n\nThis study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing.\n\nData will be compared by dependent non parametric test (Wilcoxon). P-values \\<0.05 will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsymptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy\n\nExclusion Criteria:\n\nneurological impairments'}, 'identificationModule': {'nctId': 'NCT02359604', 'briefTitle': 'The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study', 'orgStudyIdInfo': {'id': 'MUG-KCH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm Study -microbiome', 'description': 'This is a single-arm study. The patients will serve as their own controls. The PPI administered for PPI-therapy is already FDA approved. A stool sample will be obtained for intestinal microbiome testing before PPI, under PPI and after PPI therapy.', 'interventionNames': ['Drug: PPI therapy', 'Procedure: Stool sample']}], 'interventions': [{'name': 'PPI therapy', 'type': 'DRUG', 'otherNames': ['esomeprazole'], 'description': 'PPI therapy (medication has FDA approval) for 8 weeks in children with proven GERD.\n\nThe medication used (esomeprazole) in this trial is approved by the FDA', 'armGroupLabels': ['Single Arm Study -microbiome']}, {'name': 'Stool sample', 'type': 'PROCEDURE', 'description': 'Stool sample will be obtained before initiation of PPI (before PPI therapy)', 'armGroupLabels': ['Single Arm Study -microbiome']}, {'name': 'Stool sample', 'type': 'PROCEDURE', 'description': 'Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)', 'armGroupLabels': ['Single Arm Study -microbiome']}, {'name': 'Stool sample', 'type': 'PROCEDURE', 'description': 'Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).', 'armGroupLabels': ['Single Arm Study -microbiome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Department of Pediatric and Adolescent Surgery, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Christoph Castellani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Pediatric and Adolescent Surgery, Medical University Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Castellani Christoph, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}