Low FODMAP Diet in FD (PDS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The goal of this dietary intervention study is to assess the efficacy and mechanisms of a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet in functional dyspepsia patients. The main questions it aims to answer are:
* If a low-FODMAP diet can reduce dyspeptic complaints * How a low-FODMAP diet can reduce dyspeptic complaints in functional dyspepsia (FD).
Participants will follow a 6-week during low-FODMAP diet followed by powder reintroduction of 6 FODMAPs and 1 control substance.
Eligibility criteria
Qualifiers
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)
Patients must provide witnessed written informed consent prior to any study procedures being performed
Disqualifiers
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 irritable bowel syndrome (IBS) 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.
Trial design
Treatments tested in this trial
- Low-FODMAP diet
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov