NCT04270487

The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A randomized controlled trial (Phase IV trial) to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic (otilonium bromide) agent for 470 newly diagnosed or newly treated irritable bowel syndrome patients in primary care. The primary objective of this trial is to study treatment efficacy (IBS-SSS responder rate) with diet versus medication after 8 weeks of therapy. The secondary endpoint is to study the quality of life and health economic impact over six months after the start of the initial treatment with diet versus medication. Finally, patient satisfaction during and after the different treatment modalities, HRU and WPAI-IBS score in subgroups according to IBS stool pattern subtype, faecal microbiota and serotonin synthesis genetic polymorphisms will also be investigated

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	IBS Diet	Patients will be randomized to a diet or a mediation treatment
DRUG	Otilonium Bromide	Patients will be randomized to a diet or a mediation treatment

Timeline

• Start date: 2018-07-26
• Primary completion: 2020-05-04
• Completion: 2020-07-06
• First posted: 2020-02-17
• Last updated: 2020-11-17

Locations

1 site across 1 country: Belgium