RecruitingNot Applicable

Low FODMAP Diet in FD (PDS)

Belgium30 participantsStarted 2022-10-03

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients with Functional dyspepsia/ postprandial distress syndrome as per Rome IV diagnostic criteria
✓. Patients must provide witnessed written informed consent prior to any study procedures being performed
✓. Patients aged between 18 and 70 years inclusive
✓. Male or female patients

Exclusion criteria

✕. 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.
✕. Females who are pregnant or lactating are excluded from the study.

What they're measuring

Effect of a low-FODMAP diet on the LPDS (Leuven-postprandial distress scale)

Timeframe: Measurement before and after the diet (6 weeks)

Trial details

NCT IDNCT05832528

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials