Efficacy of the DOMINO Diet App in IBS

NCT05808036 | Recruiting

• 1 other identifier: S67508
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

DOMINO; Low FODMAP diet; Irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DOMINO app - DOMINO app

OTHER

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

DOMINO app - low FODMAP diet

ACTIVE COMPARATOR

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; Other: Dietary intervention: low FODMAP diet

Interventions

Dietary intervention: DOMINO app OTHER

Life style intervention and diet low in FODMAPs.

DOMINO app - DOMINO app; DOMINO app - low FODMAP diet

Dietary intervention: low FODMAP diet OTHER

Strict low FODMAP diet.

DOMINO app - low FODMAP diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Jan Tack

CONTACT

016344225; jan.tack@kuleuven.be

Karen Routhiaux

CONTACT

016372847; karen.routhiaux@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will start with the DOMINO diet. Depending on the symptom improvement they will continue the DOMINO diet or switch to the strict low FODMAP diet.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)