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NCT Number: NCT07235215

Vivatlac in Irritable Bowel Syndrome II (ViIBS2)

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

District Hospital Jarocin, Jarocin, Poland

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About this study

The study design is a multi-centre, randomized, double-blind, placebo controlled clinical trial in patients diagnosed with IBS. Diagnosis of IBS with the World Gastroenterology Organisation's IBS questionnaire for health care providers. Assessment of severity of IBS by using the IBS Severity of Symptoms Scale (IBS-SSS). IBS patients with moderate to severe IBS will be included into the study (IBS-SSS ≥ 175). A four weeks screening phase is used to evaluate 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 thirty-six 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 will be assessed by using the IBS-Severity Scoring System (IBS-SSS), before the start of treatment and after 4, 8, 12, 24, and 36 weeks of treatment. Changes of IBS severity will be assessed by using the IBS-Global Improvement Scale (IBS-GIS), before the start of treatment and after 4, 8, 12, 24, and 36 weeks of treatment. Patients will be assessed for IBS relief by using the IBS-Adequate Relief scale (IBS-AR), before the start of treatment and after 4, 8, 12, 24, and 36 weeks of treatment. Stool form characteristics will be assessed with the Bristol Stool Form Scale, before the start of treatment and after 4, 8, 12, 24, and 36 weeks treatment. Quality of life (QoL) will be assessed before the start of treatment and after 12 and 36 weeks of treatment using the IBS-QoL questionnaire. Emotional suppression will be assessed before the start of treatment and after 12 and 36 weeks of treatment using the Courtauld Emotional Control Scale (CECS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
  • IBS-SSS ≥ 175 points

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 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

Treatment and study plan

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.

Placebo

Dietary Supplement

Capsule containing maize starch with identical appearance as verum.

Primary outcomes

  1. Severity of IBS using the IBS-Severity Scoring System (IBS-SSS)

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

    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.

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

    Time frame: Measured after 12, and 36 weeks of treatment.

    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

  3. Changes in adequate relief of IBS-symptoms (IBS-AR)

    Time frame: Measured after 12, and 36 weeks of treatment.

    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.

Secondary outcomes

  1. Changes of stool form characteristics (Bristol Stool Form Scale)

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

    Type of stools assessed using the Bristol Stool Scale. Bristol Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.

  2. IBS-Quality of Life Measure (IBS-QOL)

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

    The IBS-QOL is a patient self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL consists of 34 items. Each of the items can be responded by selecting from a five-point (1-5) Likert response scale.

    The scoring procedure comprises 2 steps. In the first step a raw total score is determined by summing the individual answers (1-5). Thereafter the raw sum is transformed into a 0-100 scale.

    The formula for the transformation is:

    Score = (Sum of items) - (lowest possible raw score) / Possible raw score range × 100. "Sum of items" = sum of scores to all 34 items of the scale, "Lowest possible raw score" = if someone answers the minimum (e.g. 1) to all items, "Possible raw score range" = (maximum raw score - minimum raw score).

    A higher final score (closer to 100) indicates a poorer QOL related to IBS, lower scores a better QOL.

  3. Changes of Emotional Suppression (Courtauld Emotional Control Scale, CECS)

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

    The CECS comprises 21 statements divided into three subscales. Each subscale contains seven statements that concern the manner of showing depression, anxiety, and anger. By marking the most suitable answer, respondents assess how oftern they express emotions in a way provided in the questionnaire on a four-point scale from "almost never" - one point to "almost always" four points. The sum of the results in each subscale can range from 7-28 points. A general emotional control coefficient is calculated by adding the scores of the three subscales. The general emotional control coefficient can range from 21 to 84 points. The higher the score, the more supressed emotions are.

Study contacts

Contact information is provided by the study sponsor or research team.

Henning Sommermeyer, Dr.

CONTACT

[email protected]

+420605434344

Jacek Piatek, Prof. Dr.

CONTACT

[email protected]

+48883389788

Sponsors and collaborators

Lead sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Other

Registry information

Official study title

Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized, Double-blind, Placebo-Controlled, 36 Weeks Clinical Trial

Acronym: ViIBS2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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