Lactobacillus rhamnosus GG for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic Arizona, Scottsdale, AZ
Healthy Subjects (HS)+1 More
Lactobacillus rhamnosus GG - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Healthy Subjects (HS)

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 60 days

60 days
Adverse Events
Baseline, Day 56
Change in Observed Operational Taxonomic Unit (OTU) diversity.
Changes in Shannon diversity index.
Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.
Changes in taxa units.

Trial Safety

Trial Design

2 Treatment Groups

Lactobacillus rhamnosus GG Group
1 of 2
Placebo Group
1 of 2
Experimental Treatment
Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Lactobacillus rhamnosus GG · Has Placebo Group · N/A

Lactobacillus rhamnosus GG GroupExperimental Group · 2 Interventions: Lactobacillus rhamnosus GG, Omeprazole · Intervention Types: DietarySupplement, Drug
Placebo GroupPlaceboComparator Group · 2 Interventions: Placebo, Omeprazole · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lactobacillus rhamnosus GG
2005
Completed Phase 4
~770
Omeprazole
2006
Completed Phase 4
~940

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days
Closest Location: Mayo Clinic Arizona · Scottsdale, AZ
Photo of mayo clinic arizona 1Photo of mayo clinic arizona 2Photo of mayo clinic arizona 3
2005First Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
150 CompletedClinical Trials

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,686,131 Total Patients Enrolled
81 Trials studying Healthy Subjects (HS)
21,066 Patients Enrolled for Healthy Subjects (HS)
John DiBaise, MDPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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.).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.