RecruitingNot ApplicableNCT05517928

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

Exploratory Study of the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis


Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DRUGOmeprazole

40 MG oral capsules daily

DIETARY_SUPPLEMENTLactobacillus rhamnosus GG

Given as Culturelle Digestive Probiotic in the form of oral capsules daily

DRUGPlacebo

Oral capsules daily that look exactly like the study drug, but contains to active ingredient


Locations(1)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

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NCT05517928


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