Efficacy of the DOMINO Diet App in IBS (EDDI)

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Dietary intervention: DOMINO app; Other: Dietary intervention: low FODMAP diet

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Tack; Phone Number: 016344225; Email: jan.tack@kuleuven.be
• Study Contact Backup: Name: Karen Routhiaux; Phone Number: 016372847; Email: karen.routhiaux@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Jan Tack, Prof., MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DOMINO app - DOMINO app; The patients start with the DOMINO diet (8 weeks). Patients that experienced symptom improvement, will continue with the DOMINO diet (6 weeks).	Other: Dietary intervention: DOMINO app; Life style intervention and diet low in FODMAPs.
Active Comparator: DOMINO app - low FODMAP diet; The patients start with the DOMINO diet (8 weeks). Patients that experienced no symptom improvement, will switch to the strict low FODMAP diet (6 weeks).	Other: Dietary intervention: DOMINO app; Life style intervention and diet low in FODMAPs.; Other: Dietary intervention: low FODMAP diet; Strict low FODMAP diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom response DOMINO app and low FODMAP diet	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.	18 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Irritable bowel syndrome; Low FODMAP diet; DOMINO
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: S67508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No