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

Not Applicable

Completed

• Conditions: Functional Dyspepsia; FODMAP Diet

• Registration Number: NCT06388330
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2019-04-26
• Study First Submitted: 2020-05-06
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement on gastrointestinal symptoms	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 Outcome Measures

Name	Time	Method
Evaluation of the low FODMAP diet on IBS related symptoms	2 years	by IBS-SSS and IBS-QoL questionnares
Evaluation of the low FODMAP diet on duodenal barrier function	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).
Evaluation of the low FODMAP diet on gastric emptying	2 years	The C13-octanoic breath test was used to measure gastric emptying rate.
Evaluation of the low FODMAP diet on symptom response and quality of life	2 years	by PAGISYM and SFNDI questionnaires
Evaluation of the low FODMAP diet on depression, somatization	2 years	by PHQ
Evaluation of the low FODMAP diet on gastric accommodation	2 years	Intra-gastric pressure measurement was used to quantify gastric accommodation at baseline and at the end of the low FODMAP diet.
Reintroduction period	2 years	Percentage of patients experiencing symptom worsening upon blinded reintroduction of single FODMAPs by means of LPDS daily diaries

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium