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