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NCT Number: NCT05808036

Efficacy of the DOMINO Diet App in IBS

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Belgium

Location status: Recruiting

Location contact

Jan Tack, Prof., MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Dietary intervention: DOMINO app

Other

Life style intervention and diet low in FODMAPs.

Dietary intervention: low FODMAP diet

Other

Strict low FODMAP diet.

Primary outcomes

  1. Symptom response DOMINO app and low FODMAP diet

    Time frame: 18 months

    The symptom response is measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each question (5) is scored from 0-100, with a maximum total score of 500. Improvement is defined as a 50-point or more drop on the IBS-SSS. The score is positively correlated with severity of IBS symptoms, a score from 50-175 indicated mild disease, 175-300 moderate and >300 severe.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Tack

CONTACT

[email protected]

016344225

Karen Routhiaux

CONTACT

[email protected]

016372847

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: EDDI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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