Dose-dependent FODMAP Reintroduction in IBS (NCT05808023) | Clinical Trial Compass
CompletedNot Applicable
Dose-dependent FODMAP Reintroduction in IBS
Belgium45 participantsStarted 2023-04-01
Plain-language summary
The aim of this study is to evaluate whether symptom recurrence, after successful FODMAP elimination, is dose-dependent in patients with IBS. The effect of a blinded reintroduction of FODMAP powders fructans and mannitol will be investigated in a crossover dose-escalation scheme for the identification of the eliciting dose in individual patients. The reintroduction of FODMAPs is performed after a successful elimination by the LFD.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
✕. 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)