Irritable Bowel SyndromeEDDINCT05808036
Efficacy of the DOMINO Diet App in IBS
A study testing Dietary intervention: DOMINO app and Dietary intervention: low FODMAP diet in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Dietary intervention: DOMINO app and Dietary intervention: low FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2023to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients
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
- Being tested
- Dietary intervention: DOMINO app, Dietary intervention: low FODMAP diet
- Keywords
- DOMINO, Low FODMAP diet, Irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention: DOMINO appOther
Life style intervention and diet low in FODMAPs.
Dietary intervention: low FODMAP dietOther
Strict low FODMAP diet.
| Study group | Role | What they receive |
|---|---|---|
| DOMINO app - DOMINO app | Other | The patients start with the DOMINO diet (8 weeks). Patients that experienced symptom improvement, will continue with the DOMINO diet (6 weeks). Receives: Other: Dietary intervention: DOMINO app |
| DOMINO app - low FODMAP diet | Active comparator | 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). Receives: Other: Dietary intervention: DOMINO app; Other: Dietary intervention: low FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom response DOMINO app and low FODMAP diet
The symptom response is measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each question (5) is scored from 0-100, with a maximum total score of 500. Improvement is defined as a 50-point or more drop on the IBS-SSS. The score is positively correlated with severity of IBS symptoms, a score from 50-175 indicated mild disease, 175-300 moderate and >300 severe.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Apr 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808036
- Sponsor's protocol ID
- S67508
- Acronym
- EDDI
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the DOMINO Diet Application Versus the Low FODMAP Diet in Tertiary Care IBS Patients
- ClinicalTrials.gov ID
- NCT05808036
- Acronym / sponsor ID
- EDDI / S67508
- Conditions
- Irritable Bowel Syndrome
- Keywords
- DOMINO, Low FODMAP diet, Irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DOMINO app - DOMINO app | Other | Other: Dietary intervention: DOMINO appThe patients start with the DOMINO diet (8 weeks). Patients that experienced symptom improvement, will continue with the DOMINO diet (6 weeks). |
| DOMINO app - low FODMAP diet | Active comparator | Other: Dietary intervention: DOMINO app, Other: Dietary intervention: low FODMAP dietThe patients start with the DOMINO diet (8 weeks). Patients that experienced no symptom improvement, will switch to the strict low FODMAP diet (6 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention: DOMINO appLife style intervention and diet low in FODMAPs. | Other | DOMINO app - DOMINO app, DOMINO app - low FODMAP diet |
| Dietary intervention: low FODMAP dietStrict low FODMAP diet. | Other | DOMINO app - low FODMAP diet |
Primary outcome
Symptom response DOMINO app and low FODMAP diet
Time frame: 18 months
The symptom response is measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each question (5) is scored from 0-100, with a maximum total score of 500. Improvement is defined as a 50-point or more drop on the IBS-SSS. The score is positively correlated with severity of IBS symptoms, a score from 50-175 indicated mild disease, 175-300 moderate and >300 severe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention: DOMINO app and Dietary intervention: low FODMAP diet in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Tack (016344225, jan.tack@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom response DOMINO app and low FODMAP diet (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.