Daily Vivatlac synbiotic capsules for people with moderate-to-severe irritable bowel syndrome
Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized, Double-blind, Placebo-Controlled, 36 Weeks Clinical Trial
This trial will test whether taking one daily Vivatlac synbiotic capsule helps adults with moderate-to-severe irritable bowel syndrome feel better over 36 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz Academic / other |
| Locations | 3 sites (Jarocin and 2 other locations) |
| Trial ID | NCT07235215 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults diagnosed with IBS using the World Gastroenterology Organisation questionnaire who have moderate-to-severe symptoms (IBS-SSS ≥ 175) and are not currently taking probiotics or recent antibiotics are ideal candidates.
Not a fit: People who are pregnant, breastfeeding, have lactose intolerance, other chronic bowel diseases (like IBD or celiac), or who recently used antibiotics or probiotic products are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, the synbiotic could modestly reduce IBS symptom severity and improve stool patterns and quality of life for some patients.
How similar studies have performed: Previous trials of multi-strain probiotics and synbiotics in IBS have produced mixed but occasionally modest symptom improvements, so this approach has some supportive but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jarocin and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.