RecruitingNot ApplicableNCT05808036

Efficacy of the DOMINO Diet App in IBS

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

110 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Irritable Bowel Syndrome

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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 Criteria8

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

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