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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Low-FODMAP diet
Other intervention6-week Low-FODMAP diet in patients with functional dyspepsia
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: FD patientExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effect of a low-FODMAP diet on the LPDS (Leuven-postprandial distress scale)
Validated Leuven-postprandial distress scale for dyspeptic symptoms (0-15, higher scores indicating more severe symptoms)
Time frame
Measurement before and after the diet (6 weeks)Secondary outcomes
1
Effect of a low-FODMAP diet on urinary histamine and N-methylhistamine excretion
Via 24-hour urinary collections before and after the diet, both in microgram/g creatinin in 24h urine samples
Time frame
Measurement before and after the diet (6 weeks)2
Effect of a low-FODMAP diet on duodenal mucosal integrity
Measurement of TEER (trans epithelial electrical resistance) and Flux in Ussing Chambers as assessed in ussing chambers (If TEER increases then duodenal integrity increases, if flux increases then mucoal integrity decreases)
Time frame
Measurement before and after the diet (6 weeks)3
Effect of a low-FODMAP diet on duodenal low-grade inflammation
Mastcell and eosinophil counting
Time frame
Measurement before and after the diet (6 weeks)Sponsors and contacts
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Source ClinicalTrials.gov