Clinical trial NCT03941418: Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
Official title: Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Crohn Disease
Keywords: Saccharomyces boulardii
Lead sponsor: University Clinic Dr Dragisa Misovic-Dedinje
Sponsor class: OTHER
Collaborators: name: University Clinic Zvezdara
First posted: 2019-05-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* histological diagnosis of ulcerative colitis or Crohn disease
* colonoscopy in last six months confirming mild disease form according to endoscopic criteria (Mayo score, simple endoscopic score)
* colonoscopy in last six months confirming endoscopic remission with fulfilled clinical Rome IV criteria for irritable bowl syndrome
* patients
* patients with mild disease form are eligible only if treated with mesalazine only
* patients in remission eligible for inclusion if treated with mesalazine, biologics, azathioprine or methotrexate
* signed informed consents

Exclusion Criteria:

* no colonoscopy in last six months
* moderate to severe disease according to colonosopy findings (Mayo score, simple endoscopic score)
* indeterminate colitis

Primary outcomes:
measure: Patients quality of life
timeFrame: 8 weeks
Secondary outcomes:
measure: Disease clinical activity
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
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