Probiotics for Imbalance of Microbes

Recruiting in Palo Alto (17 mi)

Overseen byJohn DiBaise, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Trial Summary

What is the purpose of this trial?

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.

Research Team

John DiBaise, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for healthy individuals who eat a regular diet with no restrictions and have no chronic gastrointestinal symptoms. Pregnant people, those on daily GI medications, anyone with prior significant GI surgery (except appendectomy), or systemic diseases affecting GI motility are excluded.

Inclusion Criteria

Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.

I do not have any symptoms.

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.).

Exclusion Criteria

I do not have any untreated mental health issues or diseases that affect my stomach or intestines' movement.

Pregnancy.

I regularly take medication that affects my stomach or bowel movements.

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Treatment Details

Interventions

Lactobacillus rhamnosus GG (Probiotic)
Omeprazole (Proton Pump Inhibitor)
Placebo (Drug)

Trial OverviewThe study examines the effects of Lactobacillus rhamnosus GG (a probiotic) on gut health in participants taking Omeprazole, a medication that reduces stomach acid. Some will receive the probiotic while others will get a placebo to compare outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lactobacillus rhamnosus GG GroupExperimental Treatment2 Interventions

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 II: Placebo GroupPlacebo Group2 Interventions

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