Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients (ViIBS3)

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

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

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vivatlac Synbiotic

Detailed Description

The study design is a multi-centre, randomized, double-blind, placebo-controlled clinical trial in patients diagnosed with Irritable Bowel Syndrome (IBS). Diagnosis of IBS is performed with the World Gastroenterology Organisation's IBS questionnaire for health care providers. Assessment of the severity of IBS is done by using the IBS Severity Scoring System (IBS-SSS). IBS patients with moderate to severe IBS will be included in the study (IBS-SSS ≥ 175). A four-week treatment-free screening phase is used to evaluate the patients' IBS symptoms and stool characteristics using a patient diary.

The screening phase is followed by treatment with one capsule per day of a nine-strain synbiotic (Vivatlac® Synbiotikum) or with an identical-looking placebo for twelve weeks.

Each capsule of Vivatlac® Synbiotikum contains 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 ES-1, 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. In addition, each capsule contains 68 mg of fructooligosaccharides (FOS).

Treatment effects on severity of IBS symptoms is assessed by using the IBS-Severity Scoring System (IBS-SSS), before the start of treatment and after 4, 8, and 12 weeks of treatment. Changes of IBS severity is assessed by using the IBS-Global Improvement Scale (IBS-GIS), before the start of treatment and after 4, 8, and 12 weeks of treatment. Patients are assessed for IBS adequate relief by using the IBS-Adequate Relief scale (IBS-AR), after 4, 8, and 12 weeks of treatment. Stool form characteristics is assessed with the Bristol Stool Form Scale (BSFS), at the start of the screening phase, at the start of treatment, and after 4, 8, and 12 weeks of treatment.

Stool samples are taken from all patients before the start of treatment and after 12 weeks of treatment. Fecal samples will be analyzed for gut microbiota profiles using 16S rRNA sequencing (taxonomic identification of bacterial genera) and/or nanopore shotgun sequencing (species-level identification). The presence of gut inflammation will be assessed by measuring fecal calprotectin as a biomarker for gut inflammation.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacek Piatek, Prof. Dr.; Phone Number: +48883389788; Email: drpiatek@interia.eu
• Study Contact Backup: Name: Henning SOMMERMEYER, Dr.; Phone Number: +420605434344; Email: h.sommermeyer@uniwersytetkaliski.edu.pl

Study Locations

• Poland
  • Jarocin, Poland, 63-200
    • Recruiting
    • State Hospital Jarocin
    • Contact: Jacek Piatek, Prof. MD. PhD.; Phone Number: +48883389788; Email: drpiatek@interia.eu
    • Contact: Henning Sommermeyer, PhD; Phone Number: +420605434344; Email: h.sommermeyer@uniwersytetkaliski.edu.pl
    • Principal Investigator: Jacek Piatek, Prof. MD. PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Capsule containing maize starch with identical appearance as verum. One capsule taken per day before bedtime. Treatment duration 12 weeks.	Dietary supplement: Placebo; Capsule containing maize starch with identical appearance as verum.
Experimental: Vivatlac Synbiotic; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of calprotectin levels in fecal samples	Fecal samples are collected from patients and frozen as quickly as possible at -20 °C until further analysis. Samples are frozen as fast as possible at minus 20°C. Stool samples are stored at minus 20°C until further processing. Single-use Calex® Caps (Bühlmann Laboratories, Schönenbuch, Switzerland) are used according to the manufacturer's instructions to prepare samples for measurements. Calprotectin concentrations are determined using the QB® fCAL extended test (Bühlmann Laboratories, Schönenbuch, Switzerland) in combination with a Quantum Blue® Reader II BI-POCTR-ABS (Bühlmann Laboratories, Schönenbuch, Switzerland). The difference in the fecal Calprotectin concentration in stool samples taken from patients of the placebo and the synbiotic group are compared.	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)	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, 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)	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 (1 point); I feel that the symptoms have moderately worsened (2 points); I feel that the symptoms have slightly worsened (3 points); I feel no change (4 points); I feel a slight improvement (5 points); I feel moderate improvement (6 points); I feel significant improvement (7 point) IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4	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)	The IBS-Adequate Relief (IBS-AR) scale is a dichotomous single item scale 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 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)	The type of stool is assessed using the Bristol Stool Form Scale (BSFS). Pateint have to select from seven stool pictures the picture ressembling the most their own stool form. The BSFS is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.	Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.

Collaborators and Investigators

• Sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
• Investigators: Principal Investigator: Jacek Piatek, Prof. Dr., The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: synbiotic; gut microbiota; irritable bowel syndrome; fecal calprotectin; Clostridioides difficile; 16S rRNA sequencing; gut inflammation; Vivatlac synbiotic; ViIBS III trial; nanopore shotgun sequencing
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: Kalisz 2025-02 ViIBS Trial III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No