Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:35 PM
Study NCT ID:
NCT05517928
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2022-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Observed Operational Taxonomic Unit (OTU) diversity.', 'timeFrame': 'Baseline, Day 56', 'description': 'Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '60 days', 'description': 'Number of participants to report adverse events.'}, {'measure': 'Changes in Shannon diversity index.', 'timeFrame': 'Baseline, Day 56', 'description': 'Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.'}, {'measure': 'Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.', 'timeFrame': 'Baseline, Day 56', 'description': 'Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups.'}, {'measure': 'Changes in taxa units.', 'timeFrame': 'Baseline, Day 56', 'description': 'Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trial Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).\n* Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.\n* Only those with an absence of symptoms will eligible to participate.\n\nExclusion Criteria:\n\n* For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).\n* Chronic daily use of medications affecting GI secretion or motor function.\n* The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05517928', 'briefTitle': 'A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis', 'orgStudyIdInfo': {'id': '21-007621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus rhamnosus GG Group', 'description': 'Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.', 'interventionNames': ['Drug: Omeprazole', 'Dietary Supplement: Lactobacillus rhamnosus GG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.', 'interventionNames': ['Drug: Omeprazole', 'Drug: Placebo']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'description': '40 MG oral capsules daily', 'armGroupLabels': ['Lactobacillus rhamnosus GG Group', 'Placebo Group']}, {'name': 'Lactobacillus rhamnosus GG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given as Culturelle Digestive Probiotic in the form of oral capsules daily', 'armGroupLabels': ['Lactobacillus rhamnosus GG Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsules daily that look exactly like the study drug, but contains to active ingredient', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yonas Berhe, B.S', 'role': 'CONTACT', 'email': 'berhe.yonas@mayo.edu', 'phone': '480-301-6315'}], 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'centralContacts': [{'name': 'Alexandria Ramirez', 'role': 'CONTACT', 'email': 'ramirez.alexandria@mayo.edu', 'phone': '4805741853'}], 'overallOfficials': [{'name': 'John DiBaise, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John K. DiBaise', 'investigatorAffiliation': 'Mayo Clinic'}}}}