Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
End points:
End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo capsule | Placebo Comparator |
| |
| ebastine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ebastine | Drug | 20 milligram capsule once daily |
| |
| placebo capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on visceral sensitivity measured with rectal barostat. | after 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on IBS symptoms. | after 12 weeks treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guy Boeckxstaens, M.D. | Catholic University Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26752109 | Derived | Wouters MM, Balemans D, Van Wanrooy S, Dooley J, Cibert-Goton V, Alpizar YA, Valdez-Morales EE, Nasser Y, Van Veldhoven PP, Vanbrabant W, Van der Merwe S, Mols R, Ghesquiere B, Cirillo C, Kortekaas I, Carmeliet P, Peetermans WE, Vermeire S, Rutgeerts P, Augustijns P, Hellings PW, Belmans A, Vanner S, Bulmer DC, Talavera K, Vanden Berghe P, Liston A, Boeckxstaens GE. Histamine Receptor H1-Mediated Sensitization of TRPV1 Mediates Visceral Hypersensitivity and Symptoms in Patients With Irritable Bowel Syndrome. Gastroenterology. 2016 Apr;150(4):875-87.e9. doi: 10.1053/j.gastro.2015.12.034. Epub 2016 Jan 2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C058249 | ebastine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
one capsule once daily |
|
| D004066 | Digestive System Diseases |