IBS study reveals Dose-Dependent trigger foods
NCT ID NCT05808023
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether the amount of certain carbohydrates (mannitol and fructans) affects symptom return in people with irritable bowel syndrome (IBS). After a successful low-FODMAP diet, 45 participants were given increasing doses of these powders in a blinded crossover design. The goal was to find the specific dose that causes symptoms in each person.
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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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45 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Aug 2025
- 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.
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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 1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 3. 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 4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device 5. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD) 6. Patients following a diet interfering with the study diet in opinion of the investigator 7. 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.
Contacts and locations
Locations
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AZ Sint Lucas
Bruges, Belgium
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Other studies related to the condition(s) this trial covers.
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