NCT05517928NARecruitingAccepts Healthy Volunteers
A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
Mayo Clinic
Start Date
3/3/2023
Completion Date
12/1/2026
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
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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.).
* Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
* Only those with an absence of symptoms will eligible to participate.
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 psychiatric disease.
* Pregnancy.
Interventions
DRUG
Omeprazole
DIETARY_SUPPLEMENT
Lactobacillus rhamnosus GG
DRUG
Placebo
Conditions
Healthy
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States