Functional Dyspepsia and Symptom Perception

• Conditions: Dyspepsia

• Registration Number: NCT02522000
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-12
• Last Update Submitted: 2015-08-12
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)	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 Outcome Measures

Name	Time	Method
Symptom scores for psychopathology	14-day period between testday 1 and testday 2	The Patient Health Questionnaire 9 (PHQ-9) and GAD-7 questionnaires will be used for the assessment of depressive and anxiety disorders respectively.; During 7 consecutive days a digital device will be carried out for assessment of symptoms several times a day (experience sampling method/ESM).
Symptom scores for dyspepsia	14-day period between testday 1 and testday 2	Dyspeptic symptoms will be measured with two questionnaires to acquire more detailed information about complaints in patients with functional dyspepsia. The dyspepsia symptom questionnaire and the symptom checklist of the Nepean Dyspepsia Index will be used to grade the presence and intensity of dyspeptic symptoms.; In addition, participants will report dyspeptic symptoms during 14 consecutive days in an end-of-day diary.; During 7 consecutive days a digital device will be carried out for assessment of symptoms several times a day (experience sampling method/ESM).
Symptom scores for quality of life	This questionnaire is fulfilled once, in the 14-day period between testday 1 and testday 2	Quality of life will be assessed with the Health Survey 26 (SF-36) questionnaire.
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	Gastroduodenal en small intestinal permeability will be assessed with a multisugar test.
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.

Trial Locations

Locations (3)

Maastricht University Medical Center (MUMC+); 🇳🇱 Maastricht, Netherlands

Zuyderland Medical Center; 🇳🇱 Sittard-Geleen, Netherlands

St. Elisabeth Medical Center; 🇳🇱 Tilburg, Netherlands