Blocking the histamine 1 receptor by ebastine as a novel treatment in IBS

Phase 1

Conditions: Patients who suffer from irritable bowel syndrome which are diarrhea predominant and mixed (alteration of constipation and diarrhea)
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-001199-39-BE

Lead Sponsor: KULeuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Patients must meet the Rome III criteria for Irritable Bowel Syndrome:
? 3 days per month, continuous or not, in the last 3 months have abdominal discomfort or pain, with at least two of the following three characteristics:
- Reducing after defecation, and / or
- associated with a change in frequency of stool, and / or
- associated with a change of consistency / shape of the stool
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, lactation
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, analgesics).
6. Complaints arise after abdominal surgery

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Global symptom relief and relief of abdominal pain;Secondary Objective: Other IBS symptoms and quality of life;Primary end point(s): Global relief of symptoms and a decrease in abdominal pain;Timepoint(s) of evaluation of this end point: every week after the start with the medication

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): other IBS-symptoms (stool frequency and consistency, urgency, bloating, etc.) and quality of life ;Timepoint(s) of evaluation of this end point: IBS-symptoms: every week after the start with the medication<br>quality of life: 6, 12 and 14 weeks after the start with the medication