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

NCT03941418 | Unknown

• 1 other identifier: UCDragisaMisovic1
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis; Crohn Disease

Keywords

Saccharomyces boulardii

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Disease clinical activity

  8 weeks

Study Arms (2)

Boulardii

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Boulardii DIETARY_SUPPLEMENT

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.

Boulardii

Placebo DIETARY_SUPPLEMENT

Patients will be administered with placebo of same appearance, colour and taste once daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• signed informed consents

You may not qualify if:

• no colonoscopy in last six months
• moderate to severe disease according to colonosopy findings (Mayo score, simple endoscopic score)
• indeterminate colitis

Sponsors & Collaborators

• University Clinic Dr Dragisa Misovic-Dedinje: lead
• University Clinic Zvezdara: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Nikola Panic, PhD

CONTACT

+381113630600; nikola.panicmail@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 8, 2019
• Study Start: June 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share