Trial | NCT03941418  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Boulardii ...

  • Study Participants

    150
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.
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 Started
Jun 01
2019
Anticipated
Primary Completion
Mar 31
2020
Anticipated
Study Completion
Mar 31
2020
Anticipated
Last Update
May 29
2019

Dietary Supplement Boulardii

Patients will be administered with formulation containing 500 mg of Saccharomyces boulardii and 10 mg of Vitamin D3 once daily, as an addition to their standard therapy.

Dietary Supplement Placebo

Patients will be administered with placebo of same appearance, colour and taste once daily.

Boulardii Experimental

Patients will be administered with formulation containing 500 mg of Saccharomyces boulardii and 10 mg of Vitamin D3 once daily, as an addition to their standard therapy.

Placebo Placebo Comparator

Patients will be administered with placebo as an addition to their standard therapy.

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
No Results Posted