To evaluate the efficacy of a multispecies probiotics (Ecologic® BARRIER) for 12 weeks of intervention, compared with placebo on symptoms of fatigue (as measured by the Chalder Fatigue Questionnaire (CFQ)) in patients with IBD.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the difference in fatigue as measured by
the Chalder Fatigue Questionnaire (CFQ) between the probiotics and placebo
group.
Secondary outcome
The secondary endpoints of the study are 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
Current evidence about the exact cause of Inflammatory Bowel Disease (IBD)
involves a lack of balance in the intestinal microbiota, an inappropriate
immunologic response to the gut microbiota and/or a decreased intestinal
barrier function. Because of this, interest in management of the disease with
probiotics has grown markedly.
For patients with IBD, fatigue is one of the most commonly reported complaints
and a strong predictor for quality of life (QoL). Like IBD, evidence suggests
that also fatigue might be related to microbiota changes. Although several
beneficial effects of probiotics on gastrointestinal symptoms have been
identified, little research has been done on the role of probiotics in fatigue,
especially in IBD patients. Given the high prevalence of fatigue complaints of
fatigue in IBD patients, research on possible treatments is of great
importance.
Study objective
To evaluate the efficacy of a multispecies probiotics (Ecologic® BARRIER) for
12 weeks of intervention, compared with placebo on symptoms of fatigue (as
measured by the Chalder Fatigue Questionnaire (CFQ)) in patients with IBD.
Study design
Single-center, randomized, double-blinded, placebo-controlled, clinical trial
to evaluate the efficacy of multispecies probiotics (Ecologic® BARRIER), versus
placebo on symptoms of fatigue in subjects with Crohn*s disease (CD) or
ulcerative colitis (UC). Subjects will be stratified for disease and then
randomly assigned in a 1:1 ratio to receive probiotics or placebo.
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.
Study burden and risks
Subjects will be asked to fill out the above mentioned questionnaires as
indicated by the table of assessments at the start of the study, after 4 and 8
weeks of supplementation and after 12 weeks of intervention. Furthermore, daily
practice laboratory assessments will be collected during the study, as being
part of the regular visits of these subjects. Probiotics' side effects, if they
occur, tend to be mild and digestive, like flatulence or bloating, primarily in
the first week of use.
Hilvarenbeekseweg 60
Tilburg 5022GC
NL
Hilvarenbeekseweg 60
Tilburg 5022GC
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70721.028.19 |
| OMON | NL-OMON28957 |