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NOT YET RECRUITING
NCT07850960
PHASE4

Effect of Omeprazole on Gut Microbiota in Adults With Obesity and GERD

Sponsor: Federal State Budgetary Scientific Institution

View on ClinicalTrials.gov

Summary

This randomized, open-label, parallel-group study will evaluate the effect of short-term omeprazole therapy on gut and oral microbiota in adults aged 50-65 years with obesity and symptomatic gastroesophageal reflux disease. Participants will be randomized 1:1 to receive omeprazole 20 mg once daily for 14 days plus standard non-pharmacological recommendations for gastroesophageal reflux disease, or standard non-pharmacological recommendations alone. Clinical and laboratory assessments will be performed at baseline and after 14 days. Stool and saliva samples will be collected to assess gut and oral microbiota, and blood samples will be collected for laboratory biomarkers.

Official title: Effect of Proton Pump Inhibitors on Gut Microbiota Composition in Adults With Obesity and Gastroesophageal Reflux Disease

Key Details

Gender

All

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2026-09-25

Completion Date

2026-12-25

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Omeprazole

Omeprazole 20 mg administered orally once daily for 14 days.

BEHAVIORAL

Standard Non-pharmacological Recommendations for GERD

Standard non-pharmacological recommendations for gastroesophageal reflux disease management.

Locations (1)

Federal Research Centre of Nutrition, Biotechnology and Food Safety

Moscow, Russia