Evaluating the Effects of SMT04 Probiotic Supplement on Symptoms and Gut Microbiome in Adults with Irritable Bowel Syndrome

What this Trial Is About

Researchers are studying irritable bowel syndrome IBS and how probiotic supplements can improve symptoms by changing the gut microbiota. This trial focuses on SMT04, a dietary supplement containing a blend of five probiotics, including Bifidobacteria and Streptococci strains. The study aims to understand how SMT04 affects gut bacteria and IBS symptoms, using the Rome III criteria for diagnosis. This is a pilot, single-arm, open-label trial conducted at multiple centers, pooling data for analysis. Participants will take one sachet of SMT04 daily for three months. The study will track changes in gut microbiota and IBS symptoms throughout this period. This trial does not include a control group or placebo all participants receive the probiotic supplement to assess its potential effects. During the study, participants will undergo evaluations including gut microbiome analysis using tools like the Shannon index and principal coordinate analysis. IBS symptoms will be measured using the IBS severity scoring system and gastrointestinal symptom assessments. Researchers will monitor changes from baseline to three months, focusing on microbiota composition and symptom improvement. The study runs from March 2024 until December 2026.

A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)