Study of Probiotic Bacillus Coagulans MY01, Bacillus Subtilis MY02, and Ginger Extract to Improve Symptoms and Quality of Life in Adults With Functional Dyspepsia

What this Trial Is About

Functional dyspepsia FD is a common digestive disorder causing symptoms like post-meal fullness, early fullness, and stomach pain or burning without any clear structural or metabolic cause. It affects quality of life and has limited treatment options, as standard therapies often have modest effects and potential side effects. Researchers are studying whether the gut and duodenal microbiota play a role in FD and if probiotics combined with ginger extract can improve symptoms and quality of life. This trial evaluates a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger root extract 50 mg, 20% gingerols taken as one capsule daily for 8 weeks. The study involves 198 adult patients diagnosed with FD by Rome IV criteria and normal endoscopy. The trial includes two in-person visits at the start and end of the 8 weeks, plus a phone follow-up at Day 28. Participants will complete questionnaires measuring gastrointestinal symptoms and quality of life. Researchers will track treatment adherence, use of other medications, changes in lower gastrointestinal symptoms, and patient and physician impressions of symptom changes. Psychological impact will be assessed with the Hospital Anxiety and Depression Scale. Safety and tolerance will be monitored throughout the study. The main goal is to see how the supplement affects FD symptoms after 8 weeks of use.

Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)