Evaluating dose effects of FODMAP reintroduction in IBS patients

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

This study is testing how different amounts of FODMAPs affect IBS symptoms in people who have already cut them out of their diet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Brugge)
• Trial ID: NCT05808023 on ClinicalTrials.gov

What this trial studies

This study aims to determine if the recurrence of symptoms in patients with Irritable Bowel Syndrome (IBS) after eliminating FODMAPs is influenced by the amount of FODMAPs reintroduced. It employs a crossover dose-escalation design where participants will undergo a blinded reintroduction of FODMAP powders, specifically fructans and mannitol, following a successful elimination phase. The goal is to identify the specific dose that triggers symptoms in individual patients, enhancing personalized dietary management for IBS.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 diagnosed with IBS according to Rome IV criteria.

Not a fit: Patients with major psychiatric disorders or those who have experienced significant psychosomatic gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more tailored dietary recommendations for IBS patients, improving their quality of life.

How similar studies have performed: While the specific dose-dependent approach is novel, previous studies have shown promise in managing IBS symptoms through dietary interventions.

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.

Where this trial is running

Brugge

• AZ Sint Lucas — Brugge, Belgium (Recruiting)

Study contacts

• Study coordinator: Jan Tack

Conditions Irritable Bowel Syndrome; FODMAP reintroduction; Fructans; Mannitol