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Actively Recruiting

Researchers are evaluating the effects of a nine-strain synbiotic called Vivatlac Synbiotic on the gut microbiota of patients with Irritable Bowel Syndrome (IBS). This is a multi-center, randomized, double-blind, placebo-controlled clinical trial including patients diagnosed with moderate to severe IBS, based on the IBS Severity Scoring System (IBS-SSS) with scores of 175 or higher. The diagnosis is confirmed using the IBS questionnaire for health care providers from the World Gastroenterology Organization. A four-week screening phase without treatment is used to track IBS symptoms and stool characteristics through patient diaries. Participants are randomly assigned to receive either one capsule per day of Vivatlac Synbiotic or a matching placebo for twelve weeks. Each capsule of Vivatlac contains 4.5 billion colony-forming units of nine different probiotic bacteria strains along with fructooligosaccharides as a prebiotic. The placebo capsules contain maize starch and look identical to the synbiotic capsules. Treatment effects are monitored throughout the twelve weeks with assessments at weeks 4, 8, and 12. During the study, patients undergo various evaluations including IBS symptom severity scoring, global improvement assessments, and stool form tracking. Stool samples are collected before treatment and after the 12-week treatment period to analyze gut microbiota composition using 16S rRNA and nanopore shotgun sequencing methods. Additionally, fecal calprotectin levels are measured to assess gut inflammation. The study aims to understand how the synbiotic influences gut bacteria and IBS symptoms over the course of the trial.

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

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 is a multi-center, randomized, double-blind, placebo-controlled clinical trial lasting 36 weeks. Patients are selected based on an IBS Severity of Symptoms Scale score of 175 or higher, and diagnosis is confirmed using the World Gastroenterology Organisation's IBS questionnaire for healthcare providers. A four-week screening phase collects patient diaries to assess IBS symptoms and stool characteristics.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
3 locations
Jarocin Clinical Trials | DecenTrialz