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

NCT ID: NCT03941418

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-03-31

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.

Conditions

Ulcerative Colitis; Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Boulardii

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Clinic Zvezdara

UNKNOWN

Sponsor Role: collaborator

University Clinic Dr Dragisa Misovic-Dedinje

OTHER

Sponsor Role: lead

Responsible Party

Nikola Panic

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nikola Panic, PhD

Role: CONTACT

nikola.panicmail@gmail.com

+381113630600

Other Identifiers

UCDragisaMisovic1

Identifier Type: -

Identifier Source: org_study_id