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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ebastine | Active Comparator | Ebastine |
|
| placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ebastine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on global symptom relief (of IBS complaints) | By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly "SGA (Subject's Global Assessment) of relief" and "SGA of Abdominal Pain and Discomfort" questionnaires | after 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...) | By mean of weekly questionnaires | fter 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on quality of life | By mean of 'Quality of life" questionnaire (completed at the end (after 14 weeks) and the start of the study and after 8 and 12 weeks of treatment) | after 12 weeks treatment |
| Effect of treatment on inflammatory mediators/metabolites in urine |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Boeckxstaens, M.D. | Catholic University Leuven and Universitary Hospitals Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerpen | Edegem | Antwerpen | 2650 | Belgium | ||
| ZOL (Ziekenhuis Oost-Limburg) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38191268 | Derived | Decraecker L, De Looze D, Hirsch DP, De Schepper H, Arts J, Caenepeel P, Bredenoord AJ, Kolkman J, Bellens K, Van Beek K, Pia F, Peetermans W, Vanuytsel T, Denadai-Souza A, Belmans A, Boeckxstaens G. Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial. Gut. 2024 Feb 23;73(3):459-469. doi: 10.1136/gutjnl-2023-331634. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C058249 | ebastine |
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|
By metabolic profiling in urine samples before and after treatment |
| after 12 weeks |
| Genk |
| Limburg |
| 3600 |
| Belgium |
| UZ Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| AZ Sint-Elizabeth Zottegem | Zottegem | Oost-Vlaanderen | 9620 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| AZ Sint-Lucas Brugge | Bruges | West-Vlaanderen | 8310 | Belgium |
| Rijnstate | Arnhem | Gelderland | 6800 | Netherlands |
| Medisch Spectrum Twente | Enschede | Limburg | 7500 | Netherlands |
| AZ Maastricht | Maastricht | Limburg | 6202 | Netherlands |
| Sint Lucas Andreas Ziekenhuis | Amsterdam | North Holland | 1061 | Netherlands |
| Academisch Medisch Centrum | Amsterdam | North Holland | 1105 | Netherlands |
| Tergooiziekenuizen Blaricum/Hilversum | Blaricum | North Holland | 1213/1261 | Netherlands |
| D004066 | Digestive System Diseases |