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Effect of Bioflor on Gut Microbiota in Proton-Pump Inhibitor Users
Sponsor: Seoul National University Hospital
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.
Official title: Effects of Saccharomyces Boulardii Probiotics (Bioflor®) on Gut Microbiota in Proton-pump Inhibitor User
Key Details
Gender
All
Age Range
19 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-07-18
Completion Date
2025-09-18
Last Updated
2026-10-01
Healthy Volunteers
Yes
Interventions
Saccharomyces Boulardii 250 MG
Saccharomyces boulardii was administered as Bioflor® 250 Cap. (Geon-il Pharm), a hard capsule formulation containing 282.5 mg of Saccharomyces boulardii (≥5×10⁹ viable cells) per capsule. Participants in the Bioflor group took 2 capsules orally, twice daily, for 8 weeks, in addition to their PPI treatment, regardless of meal timing but at consistent times each day.
Proton Pump Inhibitors (PPI)
Proton-pump inhibitor was administered at a standard dose, orally, once daily for 8 weeks to participants in Case 1 and Case 2.
Locations (3)
Department of Internal Medicine, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea