A randomized controlled trial to investigate the efficacy of a multispecies probiotic supplement (Ecologic® BARRIER) on symptoms of fatigue in subjects with Inflammatory Bowel Disease

Recruiting

• Conditions: chronic bowel inflammation; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON55158
• Lead Sponsor: Elisabeth-Tweesteden ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

• Subjects between the ages of 18 and 75 years old.
• Subjects diagnosed with Crohn*s disease or Ulcerative Colitis.
• Subjects with a score of 4 or higher on the Chalder Fatigue Questionnaire.

Exclusion Criteria

- active inflammation
- abnormal labvalus
- use of prohbited medication
- stoma or pouch

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the difference in fatigue as measured by<br /><br>the Chalder Fatigue Questionnaire (CFQ) between the probiotics and placebo<br /><br>group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of the study are the differences in QoL indicated by<br /><br>the Inflammatory Bowel Disease Questionnaire (IBDQ) and the EuroQoL 5D<br /><br>questionnaire (EQ-5D), sleep quality examined by the Pittsburgh Sleep Quality<br /><br>Index (PSQI), stool frequency and - consistency measured by the Bristol Stool<br /><br>Scale (BSS) and standard clinical laboratory assessments.</p><br>