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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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ClinicalTrials.gov Identifier: NCT03941418
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
University Clinic Zvezdara
Information provided by (Responsible Party):
Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje

Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
Patients quality of life [ Time Frame: 8 weeks ]
Quality of life measured will be measured by questionnaire at day 1, 4 weeks after enrollment and 8 weeks after enrollment
Change History Complete list of historical versions of study NCT03941418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
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 enrollment and 8 weeks after enrollment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
Official Title  ICMJE Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Crohn Disease
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Placebo
    Patients will be administered with placebo of same appearance, colour and taste once daily.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Boulardii
  • Placebo Comparator: Placebo
    Patients will be administered with placebo as an addition to their standard therapy.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nikola Panic, PhD +381113630600 nikola.panicmail@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941418
Other Study ID Numbers  ICMJE UCDragisaMisovic1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje
Study Sponsor  ICMJE University Clinic Dr Dragisa Misovic-Dedinje
Collaborators  ICMJE University Clinic Zvezdara
Investigators  ICMJE Not Provided
PRS Account University Clinic Dr Dragisa Misovic-Dedinje
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP