Dose-dependent FODMAP Reintroduction in IBS

NCT ID: NCT05808023

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Mannitol

Mannitol belongs to the group of polyols within the FODMAPs.

Group Type: ACTIVE_COMPARATOR

FODMAP powder reintroduction

Intervention Type: OTHER

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

Fructans

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

Group Type: ACTIVE_COMPARATOR

FODMAP powder reintroduction

Intervention Type: OTHER

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

Interventions

FODMAP powder reintroduction

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

2. 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.

3. Patients with irritable bowel syndrome according to Rome IV diagnostic criteria

4. 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

1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol

2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial

3. 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

4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device

5. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)

6. Patients following a diet interfering with the study diet in opinion of the investigator

7. Patients who already followed the low FODMAP diet under guidance of a trained dietitian without success.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Lucas Brugge

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Sint Lucas

Bruges, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan Tack

Role: CONTACT

jan.tack@kuleuven.be

016 34 42 18

Karen Routhiaux

Role: CONTACT

karen.routhiaux@kuleuven.be

016 37 28 47

Facility Contacts

Joris Arts, Prof., MD

Role: primary

Other Identifiers

S67424

Identifier Type: -

Identifier Source: org_study_id