RecruitingNot ApplicableNCT07235228

Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients

Effects of Vivatlac Synbiotic on the Gut Microbiota of Patients With Irritable Bowel Syndrome - A Randomized, Double-blind, Placebo-Controlled, 12 Weeks Clinical Trial

Sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Enrollment

20 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

Irritable Bowel Syndrome

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria10

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

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Interventions

DIETARY_SUPPLEMENTVivatlac Synbiotic

Vivatlac Synbiotic containing a total of 4.5 x 10\^9 colony forming units (CFU) of nine different probiotic bacteria. Probiotic bacteria strains and their CFU amount per capsule are: Lactococcus lactis Ll-23, 9.00 x 10\^8 CFU; Lactobacillus helveticus SP 27, 9.00 x 10\^8 CFU; Bifidobacterium longum Bl-05, 6.75 x 10\^8 CFU; Bifidobacterium longum ES1, 4.50 x 10\^8 CFU; Lacticaseibacillus rhamnosus Lr-32, 4.50 x 10\^8 CFU; Streptococcus thermophiles St-21, 4.50 x 10\^8 CFU; Lacticaseibacillus casei Lc-11, 2.25 x 10\^8 CFU; Lactiplantibacillus plantarum Lp-115, 2.25 x 10\^8 CFU; Bifidobacterium bifidum Bb-02, 2.25 x 10\^8 CFU. As a prebiotic component each capsule contains 63 mg of fructooligosaccharides.

DIETARY_SUPPLEMENTPlacebo

Capsule containing maize starch with identical appearance as verum.