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Dose-dependent FODMAP Reintroduction in IBS (DORI)

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
FODMAP powder reintroduction
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome focused on measuring FODMAP reintroduction, Fructans, Mannitol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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: 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 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.

Sites / Locations

  • AZ Sint LucasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mannitol

Fructans

Arm Description

Mannitol belongs to the group of polyols within the FODMAPs.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
April 7, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
AZ Sint-Lucas Brugge
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1. Study Identification

Unique Protocol Identification Number
NCT05808023
Brief Title
Dose-dependent FODMAP Reintroduction in IBS
Acronym
DORI
Official Title
Dose-dependent Individual FODMAPs (Mannitol and Fructans) Reintroduction in Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
AZ Sint-Lucas Brugge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
FODMAP reintroduction, Fructans, Mannitol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
The patients will be blinded to both the dose and the tested powder sugar.
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mannitol
Arm Type
Active Comparator
Arm Description
Mannitol belongs to the group of polyols within the FODMAPs.
Arm Title
Fructans
Arm Type
Active Comparator
Arm Description
Fructans belong to the group of oligosaccharides, specifically the fructose-oligosaccharides (FOS), within the FODMAPs.
Intervention Type
Other
Intervention Name(s)
FODMAP powder reintroduction
Intervention Description
The FODMAP powders will be reintroduced in three different doses, each for three consecutive days.
Primary Outcome Measure Information:
Title
Dose dependency
Description
The study aims to determine the daily dose level of mannitol or fructans that induces symptom recurrence in IBS.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Tack
Phone
016 34 42 18
Email
jan.tack@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Routhiaux
Phone
016 37 28 47
Email
karen.routhiaux@kuleuven.be
Facility Information:
Facility Name
AZ Sint Lucas
City
Brugge
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joris Arts, Prof., MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose-dependent FODMAP Reintroduction in IBS

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