Dose-dependent FODMAP Reintroduction in IBS | NCT05808023

Studies
Dose-dependent FODMAP Reintroduction in IBS

NCT05808023

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Mar 20, 2026Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP powder reintroduction

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Aug 25, 2025Actual

Completion Date

Aug 25, 2025Actual

First Submitted Date

Mar 15, 2023

First Submission Date that Met QC Criteria

Apr 7, 2023

First Posted Date

Apr 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 20, 2026Actual

Name	Class
AZ Sint-Lucas Brugge	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mannitol	Active Comparator	Mannitol belongs to the group of polyols within the FODMAPs.	Other: FODMAP powder reintroduction
Fructans	Active Comparator	Fructans belong to the group of oligosaccharides, specifically the fructose-oligosaccharides (FOS), within the FODMAPs.	Other: FODMAP powder reintroduction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FODMAP powder reintroduction	Other	The FODMAP powders will be reintroduced in three different doses, each for three consecutive days.	Fructans Mannitol

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases