Efficacy of the DOMINO Diet App in IBS

NCT ID: NCT05808036

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-11-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Dietary intervention: DOMINO app

Intervention Type: OTHER

Life style intervention and diet low in FODMAPs.

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).

Group Type: ACTIVE_COMPARATOR

Dietary intervention: DOMINO app

Intervention Type: OTHER

Life style intervention and diet low in FODMAPs.

Dietary intervention: low FODMAP diet

Intervention Type: OTHER

Strict low FODMAP diet.

Interventions

Dietary intervention: DOMINO app

Life style intervention and diet low in FODMAPs.

Intervention Type: OTHER

Dietary intervention: low FODMAP diet

Strict low FODMAP diet.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan Tack

Role: CONTACT

jan.tack@kuleuven.be

016344225

Karen Routhiaux

Role: CONTACT

karen.routhiaux@kuleuven.be

016372847

Facility Contacts

Jan Tack, Prof., MD

Role: primary

Other Identifiers

S67508

Identifier Type: -

Identifier Source: org_study_id