KCE-16001: Ernährung oder Medikation bei Patienten mit Reizdarmsyndrom - DOMINO-Studie
(Niederländisch oder Französisch oder Englisch)
| Title |
A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care. (KCE-16001) |
|
Participants (P) |
Newly diagnosed or newly treated patients with IBS (based on clinical judgement of GPs who are familiar with the Rome criteria) presenting in primary care. |
|
Intervention (I) |
Dietary intervention (based on the NICE dietary guideline for IBS, adapted to Belgian food standards and culture). |
|
Control (C) |
Spasmolytic agent, otilonium bromide (most frequently prescribed IBS drug in Belgium). |
|
Outcome (O) |
The primary outcome variable is control of IBS symptoms, the proportion of responders with the two treatment arms will be compared. A responder is defined as a patient with an improvement of 50 points or more on the IBS Symptom Severity Scale. |
|
Trial Design |
A pragmatic, prospective, multi-center, open label, parallel-group, 1:1 randomized controlled trial, 8 weeks treatment, 6 months total follow-up |
|
Sample Size |
470 |
|
Trial duration |
24 Months |
|
Budget |
€ 2 122 474 (incl. VAT) |
|
Status |
Closed to recruitment - in follow up |
|
Sponsor |
UZ Leuven – KU Leuven |
|
Chief Investigator |
Prof Dr Jan Tack Department of Gastroenterology and Hepatology, Leuven University Hospitals and TARGID (Translational Research Center for Gastrointestinal Disorders), University of Leuven |
|
Trial coordinator |
Florencia Carbone Department of Gastroenterology and Hepatology, Leuven University Hospitals and TARGID (Translational Research Center for Gastrointestinal Disorders) |
|
Trial team |
| Protocol | Download here |
| Report | Q3 2020 |
| Publication | Q4 2020 |
