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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Observed Operational Taxonomic Unit (OTU) diversity.

Secondary outcome measures

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

Completed Phase 4

~770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,008 Total Patients Enrolled

John DiBaise, MDPrincipal InvestigatorMayo Clinic

Media Library

Lactobacillus rhamnosus GG (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05517928 — N/A

Healthy Subjects Research Study Groups: Placebo Group, Lactobacillus rhamnosus GG Group

Healthy Subjects Clinical Trial 2023: Lactobacillus rhamnosus GG Highlights & Side Effects. Trial Name: NCT05517928 — N/A

Lactobacillus rhamnosus GG (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05517928 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled for the trial?

"Clinicaltrials.gov affirms that this investigation is no longer recruiting participants, with the first posting dating back to January 1st 2023 and the last update on August 24th 2022. Despite not enrolling patients presently, 862 other studies are actively seeking volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

John K. DiBaise 2023. "A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517928.