drugset / Trial / NCT07852676

Summary

Proton-pump inhibitors (PPIs) are widely used to treat acid-related stomach problems, such as heartburn and acid reflux. Long-term use of PPIs has been linked to changes in the gut bacteria and fungi (called the gut microbiota), which may contribute to digestive side effects. Bioflor® is a probiotic product containing a yeast called Saccharomyces boulardii, which has been used to help with various digestive problems. However, little is known about how Bioflor affects the gut microbiota in people who are taking PPIs. This study enrolled three groups of adults at four hospitals/research centers in Korea: a control group without digestive symptoms who were not taking a PPI, a group of patients with reflux symptoms who started taking a PPI alone, and a group of patients who started taking a PPI together with Bioflor for 8 weeks. Participants completed symptom questionnaires and provided stool samples before and after treatment, which were analyzed to study changes in gut bacteria and fungi. The purpose of this study was to compare gut microbiota composition and digestive symptoms between PPI users who did and did not take Bioflor, in order to better understand the role of Bioflor in people taking PPIs.

Timeline

Start
2024-07-18
Primary completion
2025-09-18
Completion
2025-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Saccharomyces boulardii Other / unclassified 565 mg Oral