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Efficacy of the DOMINO Diet App in IBS

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  • Are you between 18 and 70 years old?

Source: NCT05808036, who can take part

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  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

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Trial details

Who runs it
Universitaire Ziekenhuizen KU Leuven
Trial code
NCT05808036
Record updated
19 March 2026
Original description
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.Read full original descriptionShow less

The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients

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.

Inclusion: 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.

Exclusion: Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial; 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; Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD); 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 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.

ClinicalTrials.gov NCT05808036