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

NCT05517928 | Recruiting

• 1 other identifier: 21-007621
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in Observed Operational Taxonomic Unit (OTU) diversity.

  Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.

  Baseline, Day 56

Secondary Outcomes (4)

• Adverse Events

  60 days

• Changes in Shannon diversity index.

  Baseline, Day 56

• Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.

  Baseline, Day 56

• Changes in taxa units.

  Baseline, Day 56

Study Arms (2)

Lactobacillus rhamnosus GG Group

EXPERIMENTAL

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.

Drug: Omeprazole; Dietary Supplement: Lactobacillus rhamnosus GG

Placebo Group

PLACEBO COMPARATOR

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.

Drug: Omeprazole; Drug: Placebo

Interventions

Omeprazole DRUG

40 MG oral capsules daily

Lactobacillus rhamnosus GG Group; Placebo Group

Lactobacillus rhamnosus GG DIETARY_SUPPLEMENT

Given as Culturelle Digestive Probiotic in the form of oral capsules daily

Lactobacillus rhamnosus GG Group

Placebo DRUG

Oral capsules daily that look exactly like the study drug, but contains to active ingredient

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trial Website

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John DiBaise, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandria Ramirez

CONTACT

4805741853; ramirez.alexandria@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: March 3, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)