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Probiotic

Probiotics for Imbalance of Microbes

N/A

Recruiting

Led By John DiBaise, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Summary

This trial will study whether the probiotic LGG can help mitigate PPI-induced changes to gut microbes.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Omeprazole may cause side effects like headaches, stomach pain, nausea, diarrhea or constipation. Probiotics like LGG are generally well-tolerated but can sometimes result in gas or bloating.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my esophagus, stomach, or intestines, but not an appendectomy.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Observed Operational Taxonomic Unit (OTU) diversity.

Secondary study objectives

Adverse Events

Changes in Shannon diversity index.

Genome

+1 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omeprazole

2006

Completed Phase 4

~940

Lactobacillus rhamnosus GG

2005