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OpenTrials
Completed

NCT Number: NCT05808023

Dose-dependent FODMAP Reintroduction in IBS

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint Lucas

Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

FODMAP powder reintroduction

Other

The FODMAP powders will be reintroduced in three different doses, each for three consecutive days.

Primary outcomes

  1. Dose dependency

    Time frame: 18 months

    The study aims to determine the daily dose level of mannitol or fructans that induces symptom recurrence in IBS.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Sint-Lucas Brugge

Registry information

Official study title

Dose-dependent Individual FODMAPs (Mannitol and Fructans) Reintroduction in Patients With Irritable Bowel Syndrome

Acronym: DORI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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