The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients

NCT ID: NCT04373304

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2021-07-01

Brief Summary

Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.

Conditions

Irritable Bowel Syndrome; FODMAP

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

low FODMAP diet

Group Type: EXPERIMENTAL

low FODMAP diet

Intervention Type: OTHER

A diet specifically developed for the management of IBS is the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, And Polyols (FODMAP) diet. FODMAP is a collective term that includes fructose in excess of glucose, oligosaccharides including fructans/fructo-oligosaccharides (FOS), galacto-oligosaccharides, sugar polyols such as sorbitol and mannitol, and lactose. Controlled studies have established efficacy of the low FODMAP in managing IBS symptoms, but this diet is complex, associated with low calorie intake, and requires individualized explanation and follow-up by an experienced dietician.

Interventions

low FODMAP diet

A diet specifically developed for the management of IBS is the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, And Polyols (FODMAP) diet. FODMAP is a collective term that includes fructose in excess of glucose, oligosaccharides including fructans/fructo-oligosaccharides (FOS), galacto-oligosaccharides, sugar polyols such as sorbitol and mannitol, and lactose. Controlled studies have established efficacy of the low FODMAP in managing IBS symptoms, but this diet is complex, associated with low calorie intake, and requires individualized explanation and follow-up by an experienced dietician.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients are eligible for the study if all of the following criteria are met:

1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria

• Symptom characteristics of IBS according to Rome IV criteria 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients

Exclusion Criteria

• Patients are excluded from the study if any of the following criteria are met:

1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study

2. Patients with 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

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

4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.

5. Females who are pregnant or lactating are excluded from the study.

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

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Dr Jan Tack

prof.dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan Tack, professor

Role: CONTACT

jan.tack@kuleuven.be

016344225

Facility Contacts

Jan Tack, professor

Role: primary

References

Van den Houte K, Colomier E, Routhiaux K, Marien Z, Schol J, Van den Bergh J, Vanderstappen J, Pauwels N, Joos A, Arts J, Caenepeel P, De Clerck F, Matthys C, Meulemans A, Jones M, Vanuytsel T, Carbone F, Tack J. Efficacy and Findings of a Blinded Randomized Reintroduction Phase for the Low FODMAP Diet in Irritable Bowel Syndrome. Gastroenterology. 2024 Jul;167(2):333-342. doi: 10.1053/j.gastro.2024.02.008. Epub 2024 Feb 23.

Reference Type: DERIVED

PMID: 38401741 (View on PubMed)

Other Identifiers

s63269

Identifier Type: -

Identifier Source: org_study_id