DORI: Dose-dependent FODMAP Reintroduction in IBS

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT05808023

Collaborator

AZ Sint-Lucas Brugge (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Other: FODMAP powder reintroduction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

The patients will follow both reintroductions of fructans and mannitol in a randomized crossover way. The reintroduction periods are separated by a washout period of three days.The patients will follow both reintroductions of fructans and mannitol in a randomized crossover way. The reintroduction periods are separated by a washout period of three days.

Masking:

Single (Participant)

Masking Description:

The patients will be blinded to both the dose and the tested powder sugar.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mannitol Mannitol belongs to the group of polyols within the FODMAPs.	Other: FODMAP powder reintroduction The FODMAP powders will be reintroduced in three different doses, each for three consecutive days.
Active Comparator: Fructans Fructans belong to the group of oligosaccharides, specifically the fructose-oligosaccharides (FOS), within the FODMAPs.	Other: FODMAP powder reintroduction The FODMAP powders will be reintroduced in three different doses, each for three consecutive days.

Arm

Intervention/Treatment

Active Comparator: Mannitol

Mannitol belongs to the group of polyols within the FODMAPs.

Other: FODMAP powder reintroduction

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

Active Comparator: Fructans

Fructans belong to the group of oligosaccharides, specifically the fructose-oligosaccharides (FOS), within the FODMAPs.

Other: FODMAP powder reintroduction

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

Outcome Measures

Primary Outcome Measures

Dose dependency [18 months]
The study aims to determine the daily dose level of mannitol or fructans that induces symptom recurrence in IBS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Sint Lucas	Brugge		Belgium

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven
AZ Sint-Lucas Brugge

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen KU Leuven

ClinicalTrials.gov Identifier:

NCT05808023

Other Study ID Numbers:

S67424

First Posted:

Apr 11, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitaire Ziekenhuizen KU Leuven

FODMAP reintroduction

Fructans

Mannitol

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Study Results

No Results Posted as of Apr 11, 2023