A randomised, placebo controlled double blind study to assess the efficacy of a probiotic dairy product containing Lactobacillus casei Shirota on symptoms, visceroperception and inflammation in Irritable Bowel Syndrome.
Recruiting
- Conditions
- Irritable Bowel Syndrome (IBS) = Prikkelbare Darm Syndroom (PDS).probiotics = probioticacytokine profiles = cytokine profielenvisceroperception = visceroperceptielowgrade inflammation = laaggradige ontsteking
- Registration Number
- NL-OMON20968
- Lead Sponsor
- Yakult Honsha Co. Ltd.1-19, 1 Chome, Higashi-ShinbashiMinato-ku 105-8660Tokyo JAPANContact person: Mr OosawaContact person in Europe: Dr S Kudo or Dr J Zhao, science managerScience department of Yakult Europe B.V.Yakult Europe B.V.Schutsluisweg 11332 EN ALMEREThe Netherlands0031(0)365211300
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients will be included when:
1. Diagnosed with IBS according to the ROME II criteria.
Exclusion Criteria
1. Patients who have had gastrointestinal surgery resulting in gastric resection, small intestinal or colonic resection.
2. Patients who are allergic to milk protein
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of the probiotic product Yakult on symptoms in patients with IBS. <br>
- Secondary Outcome Measures
Name Time Method Secondary objective:<br /><br>* To assess the effect of the probiotic product Yakult on quality of life in patients with IBS.<br /><br>Exploratory objectives:<br /><br>* To investigate the influence of the probiotic product on the intestinal flora composition of the IBS patients.<br /><br>* To characterize the intestinal flora of the IBS patients by comparison to that of the healthy volunteers.<br /><br>* To assess the effect of a 8 week treatment with the probiotic product on cytokine profiles in IBS patients.<br /><br>* To assess the difference in visceroperception before and after treatment in the intervention group vs placebo group <br /><br>* To assess the presence of low grade inflammation in sigmoid biopsies in IBS patients before and after treatment with probiotic or placebo <br>