Perifere histamine 1 receptor blokkade in PDS

Phase 2

Completed

• Conditions: Irritable bowel syndrome; 10017977

• Registration Number: NL-OMON55611
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoinst in this study is the effect of ebastine on abdominal pain<br /><br>and global relief of symptoms in IBS patients </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary, we will assess the impact on the IBS stool consistency and frequency<br /><br>and many other common complaints such as bloating, flatulence, urgency and<br /><br>feeling of incomplete evacuation. Finally, we will determine the effect of the<br /><br>treatment on the quality of life.</p><br>