Actively Recruiting
Ebastine Versus Mebeverine in IBS Patients
Led by Guy Boeckxstaens · Updated on 2026-03-23
200
Participants Needed
5
Research Sites
248 weeks
Total Duration
On this page
Sponsors
G
Guy Boeckxstaens
Lead Sponsor
F
Fund for Scientific Research, Flanders, Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome Trial rationale 1. To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine 2. To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years Primary objective To provide further evidence of the superiority of histamine 1 receptor antagonism as novel treatment for patients with non-constipated IBS, as compared to mebeverine, one of the spasmolytics currently used as first line treatment of IBS. Secondary objective(s) To provide evidence that the histamine 1 receptor antagonist ebastine is more effective in reducing abdominal pain compared to the commonly used antispasmodic mebeverine
CONDITIONS
Official Title
Ebastine Versus Mebeverine in IBS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before any screening
- Diagnosis of non-constipated IBS according to Rome IV criteria
- No organic cause explaining symptoms (excluding coeliac disease, lactose intolerance, inflammatory bowel disease, giardiasis)
- Patients with lactose intolerance included only if no improvement after 6 weeks on lactose-free diet
- Age between 18 and 65 years
You will not qualify if you...
- History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, infectious gastroenteritis, motility disorder, serious liver, kidney, heart, or lung disease, known cardiac rhythm disorders, insulin-dependent diabetes, psychiatric diseases
- Pregnancy or breastfeeding
- Use of antidepressants, antipsychotics, anti-allergic medication, or drugs affecting gastrointestinal motility or visceral sensitivity (including specific listed drug classes and CYP3A4 inducers/inhibitors)
- Symptoms started after abdominal surgery
- IBS constipation dominant subtype
- Hypersensitivity to active substances or excipients in study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
GZA
Antwerp, Antwerpen, Belgium, 2000
Actively Recruiting
2
UZA
Antwerp, Antwerpen, Belgium, 2000
Actively Recruiting
3
AZ St-Maarten
Mechelen, Antwerpen, Belgium, 2800
Actively Recruiting
4
UZLeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
5
AZ St-Lucas
Bruges, West-Vlaanderen, Belgium, 8310
Actively Recruiting
Research Team
K
Koen Bellens, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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