A 36-Week Randomized, Double-Blind Study of Vivatlac Synbiotic for Adults With Moderate to Severe Irritable Bowel Syndrome

What this Trial Is About

Researchers are investigating the effects of a nine-strain synbiotic called Vivatlac Synbiotikum in adults diagnosed with moderate to severe Irritable Bowel Syndrome IBS. This multi-center, randomized, double-blind, placebo-controlled clinical trial uses the World Gastroenterology Organisations IBS questionnaire for diagnosis and the IBS Severity of Symptoms Scale IBS-SSS to assess symptom severity, including a four-week screening phase to evaluate symptoms and stool characteristics. Participants will take one capsule daily before bedtime for 36 weeks, receiving either the Vivatlac Synbiotic or an identical placebo capsule. Each synbiotic capsule contains a blend of nine probiotic bacteria strains totaling 4.5 billion colony forming units and 63 mg of fructooligosaccharides as a prebiotic. The study compares treatment effects against placebo over the treatment period. During the trial, participants will be assessed at multiple time points using several measures IBS severity IBS-SSS, global improvement IBS-GIS, adequate symptom relief IBS-AR, stool form Bristol Stool Form Scale, quality of life IBS-QoL, and emotional suppression Courtauld Emotional Control Scale. These evaluations occur before treatment and at intervals up to 36 weeks. The trial includes safety monitoring and lasts for the full 36-week treatment duration.

Vivatlac in Irritable Bowel Syndrome II (ViIBS2)