Probiotica against fatigue in IBD
- Conditions
- Crohn's Disease or Ulcerative Colitis
- Registration Number
- NL-OMON28957
- Lead Sponsor
- Winclove B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 230
Subjects between the ages of 18 and 65 years old.
Subjects diagnosed with Crohn’s disease or Ulcerative Colitis.
Subjects with a score of 4 or higher on the Chalder Fatigue Questionnaire.
Subjects with active inflammation. Disease has to be in remission defined as CRP = 10 mg/l, leucocytes between 4.0-10.0 10E9/l and calprotectin levels of = 100 µg/g.
Subjects with abnormal laboratory values, including but not limited to hemoglobin, vitamin B12 and folic acid levels. These need to be corrected and retested before entering the study.
Subjects who used probiotics (including probiotic-containing products such as Yakult, Actimel, etc), antibiotics or Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) in the 4 weeks prior to the screening visit, or are planning to do so during the study.
Subjects with local manifestation of IBD for which surgery might be indicated or which could confound the evaluation of efficacy.
Subjects who have had placement of a stoma or pouch.
Subjects who are pregnant, lactating or planning pregnancy while enrolled in the study.
Subjects who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject’s safety or confound data interpretation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in fatigue as measured by the Chalder Fatigue Questionnaire (CFQ) between the probiotics and placebo group.
- Secondary Outcome Measures
Name Time Method The differences in QoL indicated by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the EuroQoL 5D questionnaire (EQ-5D), sleep quality examined by the Pittsburgh Sleep Quality Index (PSQI), stool frequency and - consistency measured by the Bristol Stool Scale (BSS) and standard clinical laboratory assessments.