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Effect of Bioflor on Gut Microbiota in Proton-Pump Inhibitor Users

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07852676
Lead Sponsor Seoul National University Hospital
Collaborators: Kangbuk Samsung Hospital, Sungkyunkwan University, Seoul National University Boramae Hospital, Kuhnil Pharmaceutical Co., Ltd., National Research Foundation of Korea
Conditions Dysbiosis, Gastroesophageal Reflux Disease (GERD)
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov