Irritable Bowel Syndrome (IBS)
Conditions
Brief summary
Purpose: To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine. Design: Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).
Interventions
DRUGEbastine
DRUGPlacebo
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form * age 18-65 years
Exclusion criteria
* IBS subtype with constipation * medication: antidepressants or H1-receptor antagonists * pregnancy, breast feeding * co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of treatment on global symptom relief (of IBS complaints) | after 12 weeks treatment | By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly SGA (Subject's Global Assessment) of relief and SGA of Abdominal Pain and Discomfort questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...) | fter 12 weeks treatment | By mean of weekly questionnaires |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of treatment on quality of life | after 12 weeks treatment | By mean of 'Quality of life questionnaire (completed at the end (after 14 weeks) and the start of the study and after 8 and 12 weeks of treatment) |
| Effect of treatment on inflammatory mediators/metabolites in urine | after 12 weeks | By metabolic profiling in urine samples before and after treatment |
Countries
Belgium, Netherlands
Outcome results
None listed