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

Mayo Clinic

Status: Enrolling

Conditions: Healthy

Treatments: Drug: Omeprazole; Drug: Placebo; Dietary Supplement: Lactobacillus rhamnosus GG

Study type: Interventional

Funder types: Other

Identifiers

NCT05517928

21-007621

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Lactobacillus rhamnosus GG Group

Experimental group

Description:

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.

Treatment:

Dietary Supplement: Lactobacillus rhamnosus GG

Drug: Omeprazole

Placebo Group

Placebo Comparator group

Description:

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.

Treatment:

Drug: Placebo

Drug: Omeprazole