No registrations found.
ID
Source
Brief title
Health condition
Crohn's Disease or Ulcerative Colitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in fatigue as measured by the Chalder Fatigue Questionnaire (CFQ) between the probiotics and placebo group.
Secondary outcome
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.
Background summary
RCT to investigate the efficacy of probiotic supplementation after 12 weeks of treatment on symptoms of fatigue in subjects with Inflammatory Bowel Disease.
Study objective
Subjects randomized to the probiotics group will have a lower score on the Chalder Fatigue Questionnaire after 12 weeks of treatment compared to the placebo group.
Study design
Week 0, 4, 8 and 12.
Intervention
Group A will daily receive 4 grams (2,5*109 cfu/gram) of the probiotic supplement Ecologic® BARRIER for the period of 12 weeks. Group B will be randomized to receive 4 grams of the placebo, identical in appearance, for the period of 12 weeks.
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8334 |
| CCMO | NL70721.028.19 |
| OMON | NL-OMON55158 |