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Clinical Trials/NCT02522000
NCT02522000
Unknown
Not Applicable

Symptom Perception in Patients With Functional Dyspepsia: Involvement of the TRPV-1 Neuropeptide Pathway

Maastricht University Medical Center3 sites in 1 country70 target enrollmentJuly 2015
ConditionsDyspepsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dyspepsia
Sponsor
Maastricht University Medical Center
Enrollment
70
Locations
3
Primary Endpoint
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)
Last Updated
10 years ago

Overview

Brief Summary

Functional dyspepsia (FD) is a heterogeneous disorder with multifactorial pathophysiology. Patients with FD have visceral hypersensitivity to mechanical and chemical stimuli. Several previous studies have described an increased chemosensitivity to oral capsaicin ingestion. Capsaicin is a natural agonist of TRPV-1 receptors present on afferent sensory neurons. Activation of the TRPV-1 receptor by capsaicin or other agonists results in the release of several neuropeptides (i.e. substance P, somatostatin). Besides, increased duodenal permeability and disruption of tight junction structure in FD patients compared to healthy volunteers has been reported in a recent study. In this observational study investigators will evaluate the role of the TRPV-1 neuropeptide pathway in patients with functional dyspepsia and healthy controls.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
July 2017
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)

Time Frame: Test day 1: mucosal biopsies are taken during upper gastrointestinal endoscopy

The primary outcome measure is the TRPV-1 neuropeptide pathway which includes both TRPV-1 and mucosal neuropeptide concentrations (e.g. substance P, somatostatin), assessed with real time polymerase chain reaction (PCR) and radioimmunoassay respectively.

Secondary Outcomes

  • Symptom scores for psychopathology(14-day period between testday 1 and testday 2)
  • Symptom scores for dyspepsia(14-day period between testday 1 and testday 2)
  • Symptom scores for quality of life(This questionnaire is fulfilled once, in the 14-day period between testday 1 and testday 2)
  • Postprandial symptoms after ingestion of a standardized meal(Testday 2: Postprandial symptoms are scored using a Likert scale at 15-minute intervals for a period of 240 minutes postprandial.)
  • In vivo gastroduodenal and small intestinal permeability(Day before testday 2)
  • Transcription of genes encoding for proteins involved in mucosal barrier function and symptom perception(Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy.)
  • Serotonin metabolism in mucosal tissue(Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy)
  • Serotonin metabolism in plasm(Testday 2: blood samples for serotonin analyses are taken preprandial and every 30 minutes after intake of a standardized meal during 240 minutes postprandial.)
  • Gastric emptying for solids using the 13C-sodium octanoate stable isotope breath test(Testday 2: Repeated measure: breath samples for analysis of gastric emptying are taken preprandial and every 15 minutes after intake of a standardized meal during 240 minutes postprandial.)

Study Sites (3)

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