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

Phase

N/A

Condition

N/A

Treatment

Omeprazole

Lactobacillus rhamnosus GG

Placebo

Clinical Study ID

NCT05517928

21-007621

Ages > 18
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Individuals on an unrestricted regular diet with no dietary restrictions (vegan, lowFODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittentfasting, etc.).
Healthy subjects will be screened for current or chronic GI symptoms using a 16-itemquestionnaire.
Only those with an absence of symptoms will eligible to participate.

Exclusion

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 psychiatricdisease.
Pregnancy.

Study Design