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Completed

NCT Number: NCT06388330

The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms

In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

The study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' FODMAP diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). Based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' FODMAP diet, where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed. Finally patients follow 2 weeks of a diet 'moderate' in FODMAP levels (no blinded). Blood and stool samples will be collected during the complete trial at several timepoints. In addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with functional dyspepsia (postprandial distress syndrome)
  • written informed consent
  • 18-70 years

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.

Treatment and study plan

Low fodmap diet

Other

strict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control)

Primary outcomes

  1. Improvement on gastrointestinal symptoms

    Time frame: 2 years

    The primary endpoint is to evaluate the efficacy of low FODMAP diet on gastrointestinal symptoms in FD. Based on the LPDS questionnaire (Leuven Postprandial Distress Syndrome Score), the primary endpoint is defined. This questionnaire contains questions with a scoring system from 0 till maximum 5 with higher scores indicating higher symptom severity. An improvement of 0.5 is considered clinically meaningful.

Secondary outcomes

  1. Reintroduction period

    Time frame: 2 years

    Percentage of patients experiencing symptom worsening upon blinded reintroduction of single FODMAPs by means of LPDS daily diaries

  2. Evaluation of the low FODMAP diet on IBS related symptoms

    Time frame: 2 years

    by IBS-SSS and IBS-QoL questionnares

  3. Evaluation of the low FODMAP diet on symptom response and quality of life

    Time frame: 2 years

    by PAGISYM and SFNDI questionnaires

  4. Evaluation of the low FODMAP diet on depression, somatization

    Time frame: 2 years

    by PHQ

  5. Evaluation of the low FODMAP diet on duodenal barrier function

    Time frame: 2 years

    Duodenal mucosal integrity was evaluated in adapted mini-Ussing chambers and defined by transepithelial electrical resistance (TEER) and paracellular permeability for FITC dextran (macromolecular flux) (4kDa).

  6. Evaluation of the low FODMAP diet on gastric emptying

    Time frame: 2 years

    The C13-octanoic breath test was used to measure gastric emptying rate.

  7. Evaluation of the low FODMAP diet on gastric accommodation

    Time frame: 2 years

    Intra-gastric pressure measurement was used to quantify gastric accommodation at baseline and at the end of the low FODMAP diet.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms (Postprandial Distress Syndrome According to the Rome IV Consensus)

Acronym: FFD

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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