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Functional Dyspepsia and Symptom Perception

12 agosto 2015 aggiornato da: Maastricht University Medical Center

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

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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Dispepsia

Tipo di studio

Osservativo

Iscrizione (Anticipato)

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Olanda
- - Maastricht, Olanda, 6202 AZ
    - Reclutamento
    - Maastricht University Medical Center (MUMC+)
    - Contatto:
      
      Annick Alleleyn, MD
      
      Numero di telefono: +31433884190
      
      Email: a.alleleyn@maastrichtuniversity.nl
    - Contatto:
      
      Fabiënne Smeets, MD
      
      Email: fabienne.smeets@maastrichtuniversity.nl
    - Investigatore principale:
      
      Jose Conchillo, MD PhD
  - Sittard-Geleen, Olanda
    - Non ancora reclutamento
    - Zuyderland Medical Center
    - Contatto:
      
      Annick Alleleyn, MD
      
      Numero di telefono: +31433884190
      
      Email: a.alleleyn@maastrichtuniversity.nl
    - Contatto:
      
      Fabiënne Smeets, MD
      
      Email: fabienne.smeets@maastrichtuniversity.nl
  - Tilburg, Olanda
    - Non ancora reclutamento
    - St. Elisabeth Medical Center
    - Contatto:
      
      Annick Alleleyn, MD
      
      Numero di telefono: +31433884190
      
      Email: a.alleleyn@maastrichtuniversity.nl
    - Contatto:
      
      Fabiënne Smeets, MD
      
      Email: fabienne.smeets@maastrichtuniversity.nl

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

Healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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

Inclusion criteria:

- 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.

Exclusion criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
Controlli sani
Patients with functional dyspepsia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides) Lasso di tempo: 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.	Test day 1: mucosal biopsies are taken during upper gastrointestinal endoscopy

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Symptom scores for psychopathology Lasso di tempo: 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).	14-day period between testday 1 and testday 2
Symptom scores for dyspepsia Lasso di tempo: 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).	14-day period between testday 1 and testday 2
Symptom scores for quality of life Lasso di tempo: 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.	This questionnaire is fulfilled once, in the 14-day period between testday 1 and testday 2
Postprandial symptoms after ingestion of a standardized meal Lasso di tempo: Testday 2: Postprandial symptoms are scored using a Likert scale at 15-minute intervals for a period of 240 minutes postprandial.		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 Lasso di tempo: Day before testday 2	Gastroduodenal en small intestinal permeability will be assessed with a multisugar test.	Day before testday 2
Transcription of genes encoding for proteins involved in mucosal barrier function and symptom perception Lasso di tempo: Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy.		Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy.
Serotonin metabolism in mucosal tissue Lasso di tempo: Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy		Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy
Serotonin metabolism in plasm Lasso di tempo: Testday 2: blood samples for serotonin analyses are taken preprandial and every 30 minutes after intake of a standardized meal during 240 minutes postprandial.		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 Lasso di tempo: 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.		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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Maastricht University Medical Center

Investigatori

Investigatore principale: Jose Conchillo, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2015

Completamento primario (Anticipato)

1 luglio 2017

Completamento dello studio (Anticipato)