A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Drug: Omeprazole; Dietary Supplement: Lactobacillus rhamnosus GG; Drug: Placebo

• Registration Number: NCT05517928
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2023-03-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.).
• Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
• Only those with an absence of symptoms will eligible to participate.

Exclusion Criteria

• For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).
• Chronic daily use of medications affecting GI secretion or motor function.
• The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus rhamnosus GG Group	Lactobacillus rhamnosus GG	Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.
Placebo Group	Placebo	Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.
Lactobacillus rhamnosus GG Group	Omeprazole	Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.
Placebo Group	Omeprazole	Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.

Primary Outcome Measures

Name	Time	Method
Change in Observed Operational Taxonomic Unit (OTU) diversity.	Baseline, Day 56	Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.

Secondary Outcome Measures

Name	Time	Method
Changes in Shannon diversity index.	Baseline, Day 56	Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.
Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.	Baseline, Day 56	Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups.
Adverse Events	60 days	Number of participants to report adverse events.
Changes in taxa units.	Baseline, Day 56	Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States