drugset / Trial / NCT04270487
The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-07-26
- Primary completion
- 2020-05-04
- Completion
- 2020-07-06
Publications
- Tack C, Van den Houte K, Besard L, Capiau L, Ceulemans S, Gernay O, Maes S, Peetermans C, Raat W, Stubbe J, Van Boxstael R, Vandeput O, Van Steenbergen S, Gehesquiere B, Raes J, Tack J, Carbone F. A study on the utility of inflammatory biomarkers in primary care irritable bowel syndrome: a sub analysis of the DOMINO randomized trial. BMC Gastroenterol. 2025 Dec 23;26(1):69. doi: 10.1186/s12876-025-04494-7.
- Di Rosa C, Van den Houte K, Altomare A, Guarino MPL, Besard L, Arts J, Caenepeel P, Piessevaux H, Vandenberghe A, Matthys C, Biesiekierski JR, Capiau L, Ceulemans S, Gernay O, Jones L, Maes S, Peetermans C, Raat W, Stubbe J, Van Boxstael R, Vandeput O, Van Steenbergen S, Van Oudenhove L, Vanuytsel T, Jones M, Tack J, Carbone F. DOMINO trial post hoc analysis: evaluation of the diet effects on symptoms in IBS subtypes. Ther Adv Gastroenterol. 2024 Jul 30;17:17562848241255296. doi: 10.1177/17562848241255296. eCollection 2024.
- Carbone F, Van den Houte K, Besard L, Tack C, Arts J, Caenepeel P, Piessevaux H, Vandenberghe A, Matthys C, Biesiekierski J, Capiau L, Ceulemans S, Gernay O, Jones L, Maes S, Peetermans C, Raat W, Stubbe J, Van Boxstael R, Vandeput O, Van Steenbergen S, Van Oudenhove L, Vanuytsel T, Jones M, Tack J; DOMINO Study Collaborators; Domino Study Collaborators. Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute. Gut. 2022 Nov;71(11):2226-2232. doi: 10.1136/gutjnl-2021-325821. Epub 2022 Apr 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | OTILONIUM | Small molecule | 40 mg | — |