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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

  • Clinicaltrials.gov identifier

    NCT03941418

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 8, 2019

  • Last update posted

    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
  • Allocation: Randomized
  • 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

More Information

  • Responsible Party: University Clinic Dr Dragisa Misovic-Dedinje
  • ClinicalTrials.gov Identifier: NCT03941418 History of Changes
  • Other Study ID Numbers: UCDragisaMisovic1
  • First Posted: May 8, 2019 Key Record Dates
  • 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