Evaluating the DOMINO Diet App for Irritable Bowel Syndrome

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

This study is testing if using the DOMINO diet app can help people with Irritable Bowel Syndrome manage their symptoms by following a low FODMAP diet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven)
• Trial ID: NCT05808036 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of the DOMINO diet application in managing Irritable Bowel Syndrome (IBS) among patients in a tertiary care setting. Participants will utilize the app to follow a strict low FODMAP diet, which is designed to alleviate IBS symptoms. The study will also evaluate the response rate of patients who do not initially respond to the DOMINO app by subsequently implementing the low FODMAP diet. The research will involve dietary interventions and will collect data on symptom relief and overall patient satisfaction.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 who have been diagnosed with Irritable Bowel Syndrome according to the Rome IV criteria.

Not a fit: Patients with major psychiatric disorders or those who have experienced significant psychosomatic gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a valuable digital tool for IBS patients to manage their symptoms more effectively.

How similar studies have performed: Previous studies have shown promise in using dietary interventions like the low FODMAP diet for IBS, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. 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.
3. Patients with irritable bowel syndrome according to Rome IV diagnostic criteria
4. Patients ages between 18 and 70 years old

Exclusion Criteria:

1. 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
2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
4. 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
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
6. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
7. Patients following a diet interfering with the study diet in opinion of the investigator
8. Patients who already followed the low FODMAP diet under guidance of a trained dietitian without success

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Study coordinator: Jan Tack

Conditions Irritable Bowel Syndrome; DOMINO; Low FODMAP diet; Irritable bowel syndrome