Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713969
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2020-12-17
Brief Title:
Neuro-immune Interactions and PPI
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Duodenal Neuro-immune Interactions and Effects of PPI in Functional Dyspepsia
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None