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NCT Number: NCT05517928

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

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.

Recruiting

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location status: Recruiting

Location contact

Yonas Berhe, B.S

CONTACT

[email protected]

480-301-6315

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Observed Operational Taxonomic Unit (OTU) diversity.

    Time frame: Baseline, Day 56

    Observed OTU counts in each stool sample will be tested at varying cutoffs by determining the number of OTUs per sample.

Secondary outcomes

  1. Adverse Events

    Time frame: 60 days

    Number of participants to report adverse events.

  2. Changes in Shannon diversity index.

    Time frame: Baseline, Day 56

    Observed Shannon diversity index count between PPI and placebo group compare to PPI and probiotic group.

  3. Changes in enrichment according to Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways.

    Time frame: Baseline, Day 56

    Observed changes according to KEGG pathways as compared between PPI and placebo versus PPI and probiotic groups.

  4. Changes in taxa units.

    Time frame: Baseline, Day 56

    Observed changes in taxonomic classifications as compared in PPI and placebo groups versus PPI and probiotic groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandria Ramirez

CONTACT

[email protected]

4805741853

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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