Dose-dependent FODMAP Reintroduction in IBS

NCT05808023 | Completed

• 1 other identifier: S67424
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

FODMAP reintroduction; Fructans; Mannitol

Outcome Measures

Primary Outcomes (1)

• Dose dependency

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

  18 months

Study Arms (2)

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

FODMAP powder reintroduction OTHER

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

Fructans; Mannitol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• AZ Sint-Lucas Brugge: collaborator
• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

AZ Sint Lucas

Bruges, Belgium

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be blinded to both the dose and the tested powder sugar.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: April 1, 2023
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)