Vivatlac synbiotic for gut bacteria in IBS
Effects of Vivatlac Synbiotic on the Gut Microbiota of Patients With Irritable Bowel Syndrome - A Randomized, Double-blind, Placebo-Controlled, 12 Weeks Clinical Trial
We will test whether taking one Vivatlac synbiotic capsule daily for 12 weeks changes gut bacteria and helps adults with moderate to severe IBS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz Academic / other |
| Locations | 2 sites (Jarocin and 1 other locations) |
| Trial ID | NCT07235228 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, randomized, double-blind, placebo-controlled trial with a four-week screening phase followed by 12 weeks of treatment. Eligible adults with moderate to severe IBS (IBS-SSS ≥ 175) will be randomized to one capsule per day of a nine-strain synbiotic (total 4.5 × 10^9 CFU plus 68 mg FOS) or matching placebo. Patients will record symptoms and stool characteristics in a diary and provide samples for gut microbiota analysis to compare changes between groups. The trial aims to link microbiota shifts with symptom changes under blinded, controlled conditions.
Who should consider this trial
Good fit: Adults diagnosed with IBS using the WGO IBS questionnaire who have moderate to severe symptoms (IBS-SSS ≥ 175) and who have not used probiotics or antibiotics in the past 3 months are ideal candidates.
Not a fit: People with mild IBS, recent antibiotic or probiotic use, other chronic bowel diseases, or major uncontrolled medical conditions are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, the synbiotic could reduce IBS symptoms and help normalize gut microbiota in patients with moderate to severe IBS.
How similar studies have performed: Previous probiotic and synbiotic trials in IBS have shown mixed results with some modest symptom improvements, so this approach has 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 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
Where this trial is running
Jarocin and 1 other locations
- State Hospital Jarocin — Jarocin, Poland (Recruiting)
- State Hospital Jarocin — 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.