What this study is
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.
What's being tested
- Omeprazole
Intervention · DRUG
40 MG oral capsules daily
- Lactobacillus rhamnosus GG
Intervention · DIETARY SUPPLEMENT
Given as Culturelle Digestive Probiotic in the form of oral capsules daily
- Placebo
Intervention · DRUG
Oral capsules daily that look exactly like the study drug, but contains to active ingredient
Study details
- Official title
- Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis
- Sponsor
- Mayo Clinic
- Conditions
- Healthy
- Enrolling
- 30 people
- Starts
- 2023-03-03
- Est. completion
- 2026-12
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic Arizona
Scottsdale, Arizona, United States
- Yonas Berhe, B.S · Contact480-301-6315berhe.yonas@mayo.edu
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 21-007621
Principal investigator
John DiBaise, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.