Symptom perception in patients with functional dyspepsia: involvement of the TRPV-1 neuropeptide pathway

Completed

• Conditions: Functional dyspepsia; functional stomach complaints; 10017943

• Registration Number: NL-OMON55610
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Healthy controls <= No gastrointestinal symptoms or history of gastrointestinal
disease, especially not meeting criteria for functional dyspepsia and IBS
(according to the ROME III criteria), Functional dyspepsia patients <= Patients
referred for upper gastrointestinal endoscopy by either general practitioners
or doctors from the gastroenterology outpatient clinic, meeting ROME III
criteria for functional dyspepsia

Exclusion Criteria

Healthy volunteers and functional dyspepsia patients:
1. Inability to stop the intake of NSAIDs within 14 days prior to endoscopy.
2. Inability to stop the intake of medication affecting gastrointestinal
function (e.g. proton pump inhibitors, prokinetics, laxatives) within 5 days
prior to endoscopy
3. Current use of antidepressants
4. Medical history of diabetes mellitus
5. Medical history of coeliac disease
6. Organic disease at upper gastrointestinal endoscopy (i.e. erosive
esophagitis, Barrett*s esophagus, benign esophageal stricture, Schatzki ring,
esophageal carcinoma, esophageal candidiasis, gastric ulcer, gastric erosions,
gastric cancer, duodenal erosions or duodenal ulcer).
7. First-degree family members with diabetes mellitus type I, coeliac disease,
Crohn*s disease or ulcerative colitis
8. Medical history of food allergy or anamnestic evidence of food allergy
9. Presence of coagulation disorders or use of anticoagulants
10. Dieting
11. Pregnancy or lactation
12. Smoking
13. Excessive alcohol use (>20 alcoholic consumptions/week) and inability to
avoid use of alcohol in the 2 days prior to endoscopy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the present study is to assess the involvement of the<br /><br>duodenal TRPV-1 neuropeptide pathway in symptom perception in FD patients<br /><br>compared to healthy controls. </p><br>