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

  • STATUS
    Recruiting
  • participants needed
    45
  • sponsor
    Universitaire Ziekenhuizen Leuven
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Updated on 19 February 2024
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irritable bowel syndrome
fodmap diet

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.

Details
Condition Irritable Bowel Syndrome, FODMAP
Age 18-70 years
Treatment low FODMAP diet
Clinical Study IdentifierNCT04373304
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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