KCE-16001: Ernährung oder Medikation bei Patienten mit Reizdarmsyndrom - DOMINO-Studie

Trial Description
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

 

Trial team

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

domino@uzleuven.be

Dokumente
Protocol Download here
Report Q3 2020
Publication Q4 2020
Referenzen

ClinicalTrials.gov: NCT04270487

EudraCT:  2017-003258-18

 

FINANZIERUNGSSCHEMA

Commissioning workstream 2016