Efficacy of the DOMINO Diet App in IBS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary intervention: DOMINO app, Dietary intervention: low FODMAP diet.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients
Overview
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.
Interventions
- Other Dietary intervention: DOMINO app
Life style intervention and diet low in FODMAPs. - Other Dietary intervention: low FODMAP diet
Strict low FODMAP diet.
Primary outcome measures
- Symptom response DOMINO app and low FODMAP diet [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- UZ Leuven — Leuven
Identifiers
NCT: NCT05808036 · S67508