Daily Vivatlac synbiotic capsules for people with moderate-to-severe irritable bowel syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, randomized, double-blind, placebo-controlled trial enrolling adults with IBS and an IBS-SSS score of 175 or higher. After a four-week screening period with a patient diary, participants are randomized to take one capsule per day of a nine-strain synbiotic (Vivatlac®) or matching placebo for 36 weeks. Each active capsule contains 4.5 × 10^9 CFU from nine probiotic strains plus 68 mg fructooligosaccharides (FOS). Treatment effects are measured primarily by changes in IBS symptom severity and stool characteristics using validated questionnaires and symptom diaries.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
* IBS-SSS ≥ 175 points

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 pregnant, lactating, or planning to become pregnant during the next 9 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

Where it's running

• District Hospital Jarocin
  Jarocin, Poland Recruiting
• GP Clinic Spitalna
  Jarocin, Poland Recruiting
• GP Clinic Wroclawska
  Jarocin, Poland Recruiting

Study contacts

• Principal investigator: Jacek Piatek, Prof. Dr. — The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
• Study coordinator: Jacek Piatek, Prof. Dr.
• Email: drpiatek@interia.eu
• Phone: +48883389788

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.