An interventional study of Vivatlac Synbiotic and Placebo in Irritable Bowel Syndrome, sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz. Recruiting at 3 sites in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Not applicable, Interventional, and Treatment
Multi-center,randomized, double-blind, placebo-controlled, 36 weeks trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) in IBS patients
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).
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
Capsule containing maize starch with identical appearance as verum.
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.
Time frame: 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
Time frame: 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.
Time frame: Measured after 12, and 36 weeks of treatment.
Changes of stool form characteristics (Bristol Stool Form Scale)
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.
Time frame: Measured at enrollment into treatment phase, and after 4, 8, 12, 24 , and 36 weeks of treatment.
IBS-Quality of Life Measure (IBS-QOL)
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.
Time frame: Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.
Changes of Emotional Suppression (Courtauld Emotional Control Scale, CECS)
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.
Time frame: Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.
Plan to share: No
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The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz