Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05832528

Low FODMAP Diet in FD (PDS)

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01

30

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Low FODMAP Diet in FD (PDS)

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with functional dyspepsia or postprandial distress syndrome diagnosed by Rome IV criteria
  • Symptoms of upper gastrointestinal discomfort related to meals occurring in the last 6 months
  • Negative endoscopy within the past 12 months
  • Age between 18 and 70 years inclusive
  • Male or female patients
  • Provided witnessed written informed consent before study procedures
Not Eligible

You will not qualify if you...

  • Any condition making the patient unsuitable for the study as judged by the investigator
  • Major psychiatric disorders including depression, alcohol or substance abuse within the last 2 years
  • Predominant symptoms of irritable bowel syndrome or gastro-oesophageal reflux disease
  • Changed diet in the last 3 months or previous use of the low FODMAP diet
  • Pregnant or lactating females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

KU Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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