Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03941418 Not yet recruiting May 8, 2019 May 29, 2019

study description
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.

Condition or Disease: Ulcerative Colitis
Crohn Disease
Intervention/treatment: Dietary Supplement: Boulardii
Dietary Supplement: Placebo
Phase: N/A
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.


study design
Study Type: Interventional
Estimated Enrollment : 150 participants
Intervention Model : Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
Estimated Study Start Date: June 2019
Estimated Primary Completion Date: March 2020
Estimated Study Completion Date: March 2020

Arms and interventions
Arm Intervention/treatment
Experimental: 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: 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.
Placebo Comparator: Placebo
Patients will be administered with placebo as an addition to their standard therapy.
Dietary Supplement: Placebo
Patients will be administered with placebo of same appearance, colour and taste once daily.
outcome measures
Primary Outcome Measures: 1. Patients quality of life [ Time Frame: 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 Outcome Measures: 1. Disease clinical activity [ Time Frame: 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.

Eligibility Criteria
Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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


Contacts and Locations
Contacts

Contact: Nikola Panic, PhD +381113630600 nikola.panicmail@gmail.com

Locations
Sponsors and Collaborators
University Clinic Dr Dragisa Misovic-Dedinje
University Clinic Zvezdara
Investigator
More Information
Responsible Party : University Clinic Dr Dragisa Misovic-Dedinje
ClinicalTrials.gov Identifier : NCT03941418     
Other Study ID Numbers : UCDragisaMisovic1
First Posted : May 8, 2019
Last Update Posted : May 29, 2019
Last Verified : May 2019
Individual Participant
Data (IPD) Sharing
Statement:
 
Plan to Share IPD: No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Clinic Dr Dragisa Misovic-Dedinje: Saccharomyces boulardii
Additional relevant MeSH terms :
Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer