Crohn Disease, Ulcerative Colitis
Conditions
Keywords
Saccharomyces boulardii
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.
Interventions
DIETARY_SUPPLEMENTBoulardii
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_SUPPLEMENTPlacebo
Patients will be administered with placebo of same appearance, colour and taste once daily.
Sponsors
University Clinic Zvezdara
University Clinic Dr Dragisa Misovic-Dedinje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients quality of life | 8 weeks | Quality of life measured will be measured by questionnaire at day 1, 4 weeks after enrolment and 8 weeks after enrolment. Questionnaire comprises 10 questions considering presence of symptoms of inflammatory bowel disease as well as their effect on well-being. Each question can be answered with one of seven answers contributing 1 to 7 points to final score. Final score ranges between 10 and 70 with higher values corresponding with higher quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease clinical activity | 8 weeks | Disease clinical activity will be measured by Mayo score for ulcerative colitis and Harvey-Bardshaw index for Crohn disease at day 1, 4 weeks after enrolment and 8 weeks after enrollment. The Mayo Score evaluates ulcerative colitis activity based on four clinical parameters. Each parameter of the Mayo score ranges from zero (normal or inactive disease) to 3 (severe activity). The Harvey-Bradshaw index for assessing clinical activity in patients with Crohn disease consists of 5 clinical parameters. Calculation formula for both scores considered the sum of the scores of all the parameters included. Higher values of the score are associated with increased clinical activity of the disease. |
Contacts
Primary ContactNikola Panic, PhD
Outcome results
None listed