Clinical trial NCT05808036: Efficacy of the DOMINO Diet App in IBS
Official title: The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: DOMINO
Low FODMAP diet
Irritable bowel syndrome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Symptom response DOMINO app and low FODMAP diet
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: