Can an app soothe your tummy? new IBS study says maybe
NCT ID NCT05808036
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares the DOMINO diet app to the strict low FODMAP diet for easing irritable bowel syndrome (IBS) symptoms. About 110 adults with IBS will use either the app or follow the strict diet. The goal is to see if the app works as well as the standard diet, offering a more flexible option for symptom relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DOMINO diet application (lifestyle and low-FODMAP diet tool) and strict low FODMAP diet
- What this could lead to
- If it works, the DOMINO app could offer a simpler, effective way to manage IBS symptoms without needing a strict diet.
- What could go wrong
- This is a small, early-stage study (110 people) comparing two dietary approaches, not a drug. Results may not apply to everyone, and the app may not outperform the standard diet.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UZ Leuven
RECRUITINGLeuven, Belgium
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