| NCT ID | NCT05808036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-04-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05808036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05808036 currently recruiting?
Yes, NCT05808036 is actively recruiting participants. Contact the research team at jan.tack@kuleuven.be for enrollment information.
Where is the NCT05808036 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05808036 clinical trial?
NCT05808036 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 110 participants.