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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05517928
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Omeprazole — DRUG
    40 MG oral capsules daily
  • Lactobacillus rhamnosus GG — DIETARY_SUPPLEMENT
    Given as Culturelle Digestive Probiotic in the form of oral capsules daily
  • Placebo — DRUG
    Oral capsules daily that look exactly like the study drug, but contains to active ingredient

Study Details

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.

Key Dates

Start date
Mar 3, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Lactobacillus rhamnosus GG Group
    Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.
  • Placebo Comparator: Placebo Group
    Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.

Primary Outcome Measure

Change in Observed Operational Taxonomic Unit (OTU) diversity. [ Time Frame: Baseline, Day 56 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Yonas Berhe, B.S
[email protected]
480-301-6315

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By research site
Mayo Clinic Arizona· Scottsdale, AZ

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