NCT06388330

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dyspepsia
• FODMAP Diet

Interventions

Type	Name	Description
OTHER	low FODMAP diet	strict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control)

Timeline

• Start date: 2019-04-26
• Primary completion: 2022-03-08
• Completion: 2022-03-08
• First posted: 2024-04-29
• Last updated: 2024-04-29

Locations

1 site across 1 country: Belgium