Low FODMAP diet for patients with functional dyspepsia
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms on Complaint Pattern and Urinary Histamine Excretion
This study is testing if a low-FODMAP diet can help people with functional dyspepsia feel better by reducing their symptoms after meals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT05832528 on ClinicalTrials.gov |
What this trial studies
This dietary intervention assesses the effectiveness of a low-FODMAP diet in reducing symptoms of functional dyspepsia, specifically postprandial distress syndrome. Participants will follow a 6-week low-FODMAP diet, followed by a controlled reintroduction of specific FODMAPs to evaluate symptom changes. The study aims to understand both the efficacy of the diet and the underlying mechanisms that may contribute to symptom relief in affected patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with functional dyspepsia or postprandial distress syndrome as defined by Rome IV criteria.
Not a fit: Patients with predominant symptoms of irritable bowel syndrome or gastro-oesophageal reflux disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate dyspeptic symptoms and improve the quality of life for patients with functional dyspepsia.
How similar studies have performed: Previous studies have shown promising results with low-FODMAP diets in managing gastrointestinal symptoms, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with Functional dyspepsia/ postprandial distress syndrome as per Rome IV diagnostic criteria * Symptom characteristics of dyspepsia (upper gastrointestinal symptoms occurring in the last 6 months and meal related (PDS)) * Negative endoscopy (maximum 12 months old) 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: 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 irritable bowel syndrome (IBS) 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.
Where this trial is running
Leuven, Vlaams-Brabant
- KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.