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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
2 locations
A

Actively Recruiting

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.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
3 locations