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

Primary Purpose

Ulcerative Colitis, Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Boulardii
Placebo
Sponsored by
University Clinic Dr Dragisa Misovic-Dedinje
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Saccharomyces boulardii

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Boulardii

    Placebo

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Patients quality of life
    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

    Disease clinical activity
    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.

    Full Information

    First Posted
    May 5, 2019
    Last Updated
    May 25, 2019
    Sponsor
    University Clinic Dr Dragisa Misovic-Dedinje
    Collaborators
    University Clinic Zvezdara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03941418
    Brief Title
    Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
    Official Title
    Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    March 31, 2020 (Anticipated)
    Study Completion Date
    March 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Clinic Dr Dragisa Misovic-Dedinje
    Collaborators
    University Clinic Zvezdara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis, Crohn Disease
    Keywords
    Saccharomyces boulardii

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Boulardii
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will be administered with placebo as an addition to their standard therapy.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Boulardii
    Intervention 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients will be administered with placebo of same appearance, colour and taste once daily.
    Primary Outcome Measure Information:
    Title
    Patients quality of life
    Description
    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.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Disease clinical activity
    Description
    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.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nikola Panic, PhD
    Phone
    +381113630600
    Email
    nikola.panicmail@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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