Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients

NCT07235228 | Recruiting

• 1 other identifier: Kalisz 2025-02 ViIBS Trial III
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; Vivatlac synbiotic; synbiotic; ViIBS III trial; gut microbiota; 16S rRNA sequencing; nanopore shotgun sequencing; Clostridioides difficile; fecal calprotectin; gut inflammation

Outcome Measures

Primary Outcomes (2)

• Changes of gut-microbiota composition using 16S rRNA sequencing (taxonomic identification of bacterial genera)

  Fecal samples are collected from patients and frozen as quickly as possible at -20 °C until further analysis. Samples are analyzed by 16S rRNA sequencing for a taxonomic identification of bacterial genera. Sample compositions are compared between placebo and synbiotic group before the start of the treatment and after 12 weeks of treatment.

  Measured before the start of treatment and at the end of the 12-week treatment.

• Changes of gut-microbiota composition using nanopore shotgun sequencing (species-level identification)

  Fecal samples are collected from patients and frozen as quickly as possible at -20 °C until further analysis. Samples are analyzed by nanopore shotgun sequencing for a species level identification of bacterial genera. Sample compositions are compared between placebo and synbiotic group before the start of the treatment and after 12 weeks of treatment.

  Measured before the start of treatment and at the end of the 12-week treatment

Secondary Outcomes (5)

• Measurement of calprotectin levels in fecal samples

  Measured before the start of treatment and at the end of the 12-week treatment.

• Severity of IBS using the IBS-Severity Scoring System (IBS-SSS)

  Measured at enrollment, start of the treatment phase, and after 4, 8, and 12 weeks of treatment.

• Changes of IBS severity using the IBS Global Improvement Scale (IBS-GIS)

  Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.

• Changes in adequate relief of IBS-symptoms (IBS-AR)

  Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.

• Changes of stool form characteristics with the Bristol Stool Form Scale (BSFS)

  Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsule containing maize starch with identical appearance as verum. One capsule taken per day before bedtime. Treatment duration 12 weeks.

Dietary Supplement: Placebo

Vivatlac Synbiotic

EXPERIMENTAL

Vivatlac Synbiotic for 12 weeks. One capsule containing a mixture of nine different probiotic bacteria with a total amount of 4.5 x 10\^9 colony forming units and 63 mg of fructooligosaccharides. One capsule taken per day before bedtime. Treatment duration 12 weeks.

Dietary Supplement: Vivatlac Synbiotic

Interventions

Vivatlac Synbiotic DIETARY_SUPPLEMENT

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.

Vivatlac Synbiotic

Placebo DIETARY_SUPPLEMENT

Capsule containing maize starch with identical appearance as verum.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz: lead

Study Sites (2)

State Hospital Jarocin

Jarocin, 63-200, Poland

RECRUITING

State Hospital Jarocin

Jarocin, 63-200, Poland

RECRUITING

Related Publications (6)

• Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.

  PMID: 32403297 BACKGROUND

• Sommermeyer H, Pituch HM, Wultanska D, Wojtyla-Buciora P, Piatek J, Bernatek M. Inhibition of Quinolone- and Multi-Drug-Resistant Clostridioides Difficile Strains by Multi Strain Synbiotics-An Option for Diarrhea Management in Nursing Facilities. Int J Environ Res Public Health. 2021 May 30;18(11):5871. doi: 10.3390/ijerph18115871.

  PMID: 34070727 BACKGROUND

• Piatek J, Sommermeyer H, Bernatek M, Ciechelska-Rybarczyk A, Oleskow B, Mikkelsen LS, Barken KB. Persistent infection by Salmonella enterica servovar Typhimurium: are synbiotics a therapeutic option? - a case report. Benef Microbes. 2019 Mar 13;10(2):211-217. doi: 10.3920/BM2018.0080. Epub 2018 Dec 21.

  PMID: 30574800 BACKGROUND

• Sommermeyer H, Piatek J. Synbiotics as Treatment for Irritable Bowel Syndrome: A Review. Microorganisms. 2024 Jul 21;12(7):1493. doi: 10.3390/microorganisms12071493.

  PMID: 39065261 BACKGROUND

• Sommermeyer H, Chmielowiec K, Bernatek M, Olszewski P, Kopczynski J, Piatek J. Results from a Cross-Sectional Observational Study Examining Irritable Bowel Syndrome Patients Six Months After Finishing Their Participation in the ViIBS Trial. Nutrients. 2024 Nov 15;16(22):3911. doi: 10.3390/nu16223911.

  PMID: 39599697 BACKGROUND

• Sommermeyer H, Chmielowiec K, Bernatek M, Olszewski P, Kopczynski J, Piatek J. Effectiveness of a Balanced Nine-Strain Synbiotic in Primary-Care Irritable Bowel Syndrome Patients-A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 May 16;16(10):1503. doi: 10.3390/nu16101503.

  PMID: 38794741 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jacek Piatek, Prof. Dr.

  The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacek Piatek, Prof. Dr.

CONTACT

+48883389788; drpiatek@interia.eu

Henning Sommermeyer, Dr.

CONTACT

+420605434344; h.sommermeyer@uniwersytetkaliski.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized allocation of IBS patients to a synbiotic or a placebo group of similar size

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)