NCT04713969

Neuro-immune Interactions and PPI

Duodenal Neuro-immune Interactions and Effects of PPI in Functional Dyspepsia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Prospective interventional study on duodenal neuro-immune interactions in healthy volunteers and functional dyspepsia patients and the effects of PPI

Detailed description

Duodenal low-grade inflammation is frequently reported in functional dyspepsia (FD), while also neuronal and structural changes in duodenal submucosal ganglia have been described in FD patients. Proton pump inhibitors (PPI) are the first-line therapy in FD patients and are recently shown to have anti-inflammatory properties in FD. However, the exact mechanism of their anti-inflammatory action is unknow and their effect on duodenal nerve signalling remain unclear. In this prospective interventional study, FD patients will undergo study procedures before and after treatment with pantoprazole (Pantomed®) 40mg twice daily during 4 weeks, with a baseline comparison to healthy volunteers. This study aims to provide an in-deep characterization of the inflammatory infiltrate in the duodenum of FD patients, and to unravel the effect of PPI-therapy on neuronal signalling, duodenal inflammation and neuro-immune interactions in FD. Novel insights in the pathophysiology of FD, including the duodenal mucosal inflammation and impaired neuronal functioning, can provide a better understanding of this commonly and costly disorder. Moreover, these results will help to elucidate the anti-inflammatory effect of PPI, which will contribute to the discovery of predictive markers for therapeutic efficacy of PPI in FD.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Pantoprazole 40mg	Pantoprazole 40mg twice daily

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-01-10
• Completion: 2024-09-23
• First posted: 2021-01-19
• Last updated: 2025-01-28

Locations

1 site across 1 country: Belgium