Study of a Probiotic Supplement to Support Treatment for Adults Aged 40 to 55 With Reflux Disease on PPI Therapy

What this Trial Is About

Researchers are evaluating a probiotic dietary supplement as supportive treatment for patients diagnosed with gastroesophageal reflux disease GERD who are currently on proton pump inhibitor PPI therapy. This early phase 1, two-arm, double-blind, randomized, placebo-controlled study aims to assess how the probiotic affects the diversity and composition of the gut microbiome. The study also monitors changes in the oral microbiome, patient quality of life, and GERD symptoms to better understand probiotic supplementation effects. Participants will take either the probiotic supplement or a placebo, both administered as 2 tablets twice dailyonce in the morning before meals and once in the evening after mealsfor six weeks. If any adverse effects occur, supplementation will be stopped. Oral and rectal swabs will be collected before and after the supplementation period to analyze microbiome changes. During the study, patients will regularly complete questionnaires to track their GERD symptoms and any adverse events. The primary outcome is the change in the percentage of patients with gastrointestinal dysbiosis caused by GERD or its treatment, measured from enrollment to the end of supplementation. Secondary outcomes include symptom changes assessed by standardized scores and evaluation of the safety and tolerability of the probiotic. Participation lasts for six weeks of supplementation with ongoing monitoring throughout.

Development of a Preparation for Supportive Supplementation of Probiotics in Patients With Reflux