Functional Dyspepsia and Symptom Perception

NCT02522000 | Unknown DMC

• 1 other identifier: METC142070
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (9)

• 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

Study Arms (2)

Patients with functional dyspepsia

Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 patients with functional dyspepsia and 20 healthy controls will be included

You may qualify if:

• \- No gastrointestinal symptoms or history of gastrointestinal disease meeting ROME III criteria for functional dyspepsia and Irritable Bowel Syndrome (IBS).

You may not qualify if:

• Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14 days prior to endoscopy and within two days prior to multi-sugar test.
• Inability to stop the intake of medication affecting gastrointestinal function (e.g. proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy, multi-sugar test and combined meal- and gastric emptying test
• Current use of antidepressants
• Medical history of diabetes mellitus
• Medical history of coeliac disease
• 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)
• First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's disease or ulcerative colitis
• Medical history of food allergy or anamnestic evidence of food allergy
• Presence of coagulation disorders or use of the following anticoagulants: coumarin derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy controls using higher doses of calcium carbasalate will be excluded from the study).
• Dieting
• Pregnancy or lactation
• Smoking
• Excessive alcohol use (\>20 alcoholic consumptions/week) and inability to avoid use of alcohol in the 2 days prior to endoscopy and multi-sugar test
• Functional dyspepsia patients
• \- Patients referred for upper gastrointestinal endoscopy by either general practitioners or physicians from the gastroenterology outpatient clinic and meeting ROME III criteria for functional dyspepsia.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (3)

Maastricht University Medical Center (MUMC+)

Maastricht, 6202 AZ, Netherlands

RECRUITING

Zuyderland Medical Center

Sittard-Geleen, Netherlands

NOT YET RECRUITING

St. Elisabeth Medical Center

Tilburg, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Conchillo, MD, PhD

  Maastricht University Medical Center, Maastricht, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annick Alleleyn, MD

CONTACT

+31433884190; a.alleleyn@maastrichtuniversity.nl

Fabiënne Smeets, MD

CONTACT

fabienne.smeets@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 13, 2015

Record last verified: 2015-07

Locations

NL (3)