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

Functional Dyspepsia Clinical Trial

— FFD  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06388330
• Other study ID #: s61692
• Status: Completed
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: March 8, 2022

Study information

• Verified date: April 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

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

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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