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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-03

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lactobacillus rhamnosus GG Group

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

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

40 MG oral capsules daily

Lactobacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Omeprazole

Intervention Type DRUG

40 MG oral capsules daily

Placebo

Intervention Type DRUG

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

Interventions

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Omeprazole

40 MG oral capsules daily

Intervention Type DRUG

Lactobacillus rhamnosus GG

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes