Efficacy of the DOMINO Diet App in IBS

Recruiting now · Not applicable

Conditions studied: Irritable Bowel Syndrome

In brief

The aim of this study is to evaluate whether the DOMINO diet application is an effective tool in the treatment of Irritable bowel syndrome in tertiary care. Furthermore, this study aims to determine the response rate of the strict low FODMAP diet in non-responders to the DOMINO diet.

Key facts

Study ID

NCT05808036

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

110

Starts

2023-04-01

Expected to finish

2026-08-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
• Patients with irritable bowel syndrome according to Rome IV diagnostic criteria
• Patients ages between 18 and 70 years old

You may not qualify if…

• Participant has a history of any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
• Patients following a diet interfering with the study diet in opinion of the investigator
• Patients who already followed the low FODMAP diet under guidance of a trained dietitian without success

Where it is running

• UZ Leuven — Leuven, Belgium (enrolling)

Full record on ClinicalTrials.gov

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