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Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease

Ulcerative Colitis Clinical Trial

Official title:
Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease

Clinical Trial Summary

The goal of the study is to assess the impact of treatment with dietary supplement containing Saccharomyces boulardii (used as an addition to standard therapy), on quality of life of patients with mild forms of ulcerative colitis and Crohn disease, as well as those in remission fulfilling criteria for irritable bowel syndrome.

Patients included will be randomly assigned in two groups and subsequently administered with formulation containing Saccharomyces boulardii or placebo for 4 weeks. Patient's quality of life will be assessed by questionnaire at the enrolment and 4 weeks after initiating the therapy.

Clinical Trial Description

Saccharomyces boulardii has been reported to have positive impact on intestinal epithelial barrier as well as immune system. It has been proven to be efficient in treatment and prophylaxis of travellers diarrhoea, HIV associated diarrhoea, antibiotics associated diarrhoea and Clostridium difficile infection. However there is a limited data available on effect of therapy with Saccharomyces boulardii (as add-on to standard therapy) in patients with inflammatory bowel disease. Nevertheless, knowing the effect Saccharomyces boulardii has on intestinal flora, intestinal epithelium and immune system it can be hypothesised that Saccharomyces boulardii used as add-on to standard therapy in IBD patients can lead to improvement in symptoms and therefore in quality of life. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03941418
Study type Interventional
Source University Clinic Dr Dragisa Misovic-Dedinje
Contact Nikola Panic, PhD
Phone +381113630600
Email nikola.panicmail@gmail.com
Status Not yet recruiting
Phase N/A
Start date June 1, 2019
Completion date March 31, 2020
View Details
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