Vivatlac in Irritable Bowel Syndrome II (ViIBS2)

NCT07235215 | Recruiting

• 1 other identifier: Kalisz 2025-01 ViIBS Trial II
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Multi-center,randomized, double-blind, placebo-controlled, 36 weeks trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) in IBS patients

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; Vivatlac synbiotic; ViIBS2 trial; synbiotic

Outcome Measures

Primary Outcomes (3)

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

  IBS-Severity Scoring System is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 50 points is associated with a clinically meaningful improvement.

  Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.

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

  Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given? The answers are recorded based on the 7-point scale: * I feel that the symptoms have worsened significantly * I feel that the symptoms have moderately worsened * I feel that the symptoms have slightly worsened * I feel no change * I feel a slight improvement * I feel moderate improvement * I feel significant improvement IBS-GIS score indicates: improvement if is \>4 or worsening if is\<4, no change if is 4

  Measured after 12, and 36 weeks of treatment.

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

  IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms? The answer is YES or NO.

  Measured after 12, and 36 weeks of treatment.

Secondary Outcomes (3)

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

  Measured at enrollment into treatment phase, and after 4, 8, 12, 24 , and 36 weeks of treatment.

• IBS-Quality of Life Measure (IBS-QOL)

  Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.

• Changes of Emotional Suppression (Courtauld Emotional Control Scale, CECS)

  Measured at enrollment into treatment phase, and after 12, and 36 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 36 weeks.

Dietary Supplement: Placebo

Vivatlac Synbiotic

EXPERIMENTAL

Vivatlac Synbiotic for 36 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 36 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-SSS ≥ 175 points

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 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

Sponsors & Collaborators

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

Study Sites (3)

District Hospital Jarocin

Jarocin, 63-200, Poland

RECRUITING

GP Clinic Spitalna

Jarocin, 63-200, Poland

RECRUITING

GP Clinic Wroclawska

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 verum or 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 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)