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

Universitaire Ziekenhuizen KU Leuven32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Functional Dyspepsia FODMAP Diet

Interventions

low FODMAP dietOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with functional dyspepsia (postprandial distress syndrome) * written informed consent * 18-70 years Exclusion Criteria: 1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study 2. 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 3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD) 4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study. 5. Females who are pregnant or lactating are excluded from the study.

Locations (1)

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

Improvement on gastrointestinal symptoms

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.

Time frame: 2 years

Secondary Outcomes

Reintroduction period

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

Time frame: 2 years

Evaluation of the low FODMAP diet on IBS related symptoms

by IBS-SSS and IBS-QoL questionnares

Time frame: 2 years

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

by PAGISYM and SFNDI questionnaires

Time frame: 2 years

Evaluation of the low FODMAP diet on depression, somatization

by PHQ

Time frame: 2 years

Evaluation of the low FODMAP diet on duodenal barrier function

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).

Time frame: 2 years

Evaluation of the low FODMAP diet on gastric emptying

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

Data from ClinicalTrials.gov

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