Irritable bowel syndrome
Conditions
Interventions
12 weeks treatment with placebo or Ebastine
Sponsors
UZ Leuven
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients meet the ROME III criteria for IBS and is NOT diagnosed with the constipation dominant subform of IBS (IBS-C), 2. No identifiable organic explanation for the symptoms (including the execution of a test for lactose intolerance, celiac disease and giardia test), 3. Age 18-65 years, 4. Signed informed consent, 5. Symptoms during the two weeks of screening
Exclusion criteria
Exclusion criteria: 1. IBS constipation dominant, 2. Patient with history of:, Celiac disease, Known milk allergy, giardiasis, inflammatory bowel disease, active intestinal infection, chronic intestinal ischemia, chronic subobstruction, pseudo-obstruction, dumping syndrome, pancreatic insufficiency, hepatic impairment, renal function impairment, cardiovascular disease, extensive gastrectomy and/or bowel resection, active malignant disease, thyroiddysfunction, insulin dependent diabetes mellitus, psychiatric disorder, any clinical condition in which the researcher does not allow to terminate the study safely, 3. Pregnancy, breastfeeding, 4. Medication: Use of anti-allergica, antidepressants, and antipsychotics, 5. Patient uses drugs that reduce gastrointestinal motility and / or affect the visceral perception (anticholinergics, antispasmodics, 5-HT4 agonists, cholinomimetics, loperamide, laudanum, codeine, stimulant laxatives, macrogol, paraffin oil, anti-inflammatory agents) OR mediaction knwon to prolong QTc-interval (antifungals (ketoconazol) and macrolides (erytromycien, claritromycine))., 6. Complaints arise after abdominal surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoinst in this study is the effect of ebastine on abdominal pain and global relief of symptoms in IBS patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary, we will assess the impact on the IBS stool consistency and frequency and many other common complaints such as bloating, flatulence, urgency and feeling of incomplete evacuation. Finally, we will determine the effect of the treatment on the quality of life. | — |
Countries
Netherlands
Outcome results
None listed