A 12-Week Study of Vivatlac Synbiotic Effects on Gut Bacteria in Adults with Moderate to Severe Irritable Bowel Syndrome

What this Trial Is About

Researchers are evaluating the effects of a nine-strain synbiotic called Vivatlac Synbiotikum on the gut microbiota of patients with Irritable Bowel Syndrome IBS. This multi-center, randomized, double-blind, placebo-controlled trial includes IBS patients diagnosed using the World Gastroenterology Organisations questionnaire and with moderate to severe symptoms assessed by the IBS Severity Scoring System IBS-SSS. Participants undergo a four-week screening phase without treatment to track IBS symptoms and stool characteristics using a diary. Then, they are randomly assigned to receive either one capsule daily of Vivatlac Synbiotic, containing nine probiotic strains and fructooligosaccharides, or a placebo capsule for 12 weeks. Treatment effects on IBS severity and gut microbiota are measured throughout the study. During the study, participants complete symptom assessments at several points, including IBS-SSS, IBS Global Improvement Scale, and stool form evaluations. Stool samples are collected before and after treatment to analyze gut bacteria and inflammation markers. The primary outcome is changes in gut microbiota composition measured by sequencing methods before and after 12 weeks of treatment. Participants are monitored closely over this period to assess treatment impact and safety.

Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients