Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients (NCT07235228) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients
Poland20 participantsStarted 2025-11-21
Plain-language summary
Multi-center, randomized, double-blind, placebo-controlled, 12 weeks trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) on the gut microbiota of IBS patients
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
* IBS severity assessed with the IBS-Severity Scoring System (IBS-SSS) being ≥ 175 points (indicating medium or severe IBS).
Exclusion Criteria:
* patients currently taking products containing probiotics or have taken this kind of products during the last 3 months
* patients currently taking antibiotics or have taken antibiotics during the last 3 months
* patients having a concurrent severe illness (malignancies, uncontrolled hypertension or diabetes, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma or COPD, hyper- or hypothyroidism
* patients having chronic bowel disorders other than IBS, including inflammatory bowel disease, gastroenteritis, stomach and duodenal cancer, celiac disease
* patient being tested positive for presence of Clostridioides difficile
* patient being pregnant, lactating, or planning to become pregnant during the next 3 months
* patient being diagnosed to have a lactose intolerance
* patients using motility drugs or dietary fiber supplements withing 2 weeks before study start
* patient taking anti-coagulant medication
* patients have participated in another clinical trial within the last three months
What they're measuring
1
Changes of gut-microbiota composition using 16S rRNA sequencing (taxonomic identification of bacterial genera)
Timeframe: Measured before the start of treatment and at the end of the 12-week treatment.
2
Changes of gut-microbiota composition using nanopore shotgun sequencing (species-level identification)
Timeframe: Measured before the start of treatment and at the end of the 12-week treatment
Trial details
NCT IDNCT07235228
SponsorThe President Stanisław Wojciechowski State University of Applied Sciences in Kalisz