A Phase 4 interventional study of Ebastine and Placebo in Irritable Bowel Syndrome (IBS), sponsored by KU Leuven. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by KU Leuven · Phase 4, Interventional, and Treatment
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).
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 200 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ebastine
Drug: Ebastine
Placebo
Drug: Placebo
Effect of treatment on global symptom relief (of IBS complaints)
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
Time frame: after 12 weeks treatment
Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
By mean of weekly questionnaires
Time frame: fter 12 weeks treatment
Effect of treatment on quality of life
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)
Time frame: after 12 weeks treatment
Effect of treatment on inflammatory mediators/metabolites in urine
By metabolic profiling in urine samples before and after treatment
Time frame: after 12 weeks
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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KU Leuven