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

University Clinic Dr Dragisa Misovic-Dedinje

Status: Unknown

Conditions: Ulcerative Colitis; Crohn Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Boulardii

Study type: Interventional

Funder types: Other

Identifiers

NCT03941418

UCDragisaMisovic1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Boulardii

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Boulardii

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo