Status:
UNKNOWN
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Irritable Bowel Syndrome
FODMAP
Eligibility:
All Genders
18-70 years
Phase:
NA
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 differ...
Eligibility Criteria
Inclusion
- 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
- Patients are excluded from the study if any of the following criteria are met:
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- 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
- Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
- Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
- Females who are pregnant or lactating are excluded from the study.
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04373304
Start Date
November 25 2019
End Date
July 1 2021
Last Update
May 8 2020
Active Locations (1)
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1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000