- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02522000
Functional Dyspepsia and Symptom Perception
Symptom Perception in Patients With Functional Dyspepsia: Involvement of the TRPV-1 Neuropeptide Pathway
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Maastricht, Pays-Bas, 6202 AZ
- Recrutement
- Maastricht University Medical Center (MUMC+)
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Contact:
- Annick Alleleyn, MD
- Numéro de téléphone: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
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Contact:
- Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
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Chercheur principal:
- Jose Conchillo, MD PhD
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Sittard-Geleen, Pays-Bas
- Pas encore de recrutement
- Zuyderland Medical Center
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Contact:
- Annick Alleleyn, MD
- Numéro de téléphone: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
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Contact:
- Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
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Tilburg, Pays-Bas
- Pas encore de recrutement
- St. Elisabeth Medical Center
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Contact:
- Annick Alleleyn, MD
- Numéro de téléphone: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
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Contact:
- Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Contrôles sains
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Patients with functional dyspepsia
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)
Délai: Test day 1: mucosal biopsies are taken during upper gastrointestinal endoscopy
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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.
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Test day 1: mucosal biopsies are taken during upper gastrointestinal endoscopy
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Symptom scores for psychopathology
Délai: 14-day period between testday 1 and testday 2
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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
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Symptom scores for dyspepsia
Délai: 14-day period between testday 1 and testday 2
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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
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Symptom scores for quality of life
Délai: This questionnaire is fulfilled once, in the 14-day period between testday 1 and testday 2
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Quality of life will be assessed with the Health Survey 26 (SF-36) questionnaire.
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This questionnaire is fulfilled once, in the 14-day period between testday 1 and testday 2
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Postprandial symptoms after ingestion of a standardized meal
Délai: Testday 2: Postprandial symptoms are scored using a Likert scale at 15-minute intervals for a period of 240 minutes postprandial.
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Testday 2: Postprandial symptoms are scored using a Likert scale at 15-minute intervals for a period of 240 minutes postprandial.
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In vivo gastroduodenal and small intestinal permeability
Délai: Day before testday 2
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Gastroduodenal en small intestinal permeability will be assessed with a multisugar test.
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Day before testday 2
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Transcription of genes encoding for proteins involved in mucosal barrier function and symptom perception
Délai: Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy.
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Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy.
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Serotonin metabolism in mucosal tissue
Délai: Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy
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Testday 1: gastric and duodenal biopsies are taken during upper gastrointestinal endoscopy
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Serotonin metabolism in plasm
Délai: Testday 2: blood samples for serotonin analyses are taken preprandial and every 30 minutes after intake of a standardized meal during 240 minutes postprandial.
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Testday 2: blood samples for serotonin analyses are taken preprandial and every 30 minutes after intake of a standardized meal during 240 minutes postprandial.
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Gastric emptying for solids using the 13C-sodium octanoate stable isotope breath test
Délai: 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.
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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.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jose Conchillo, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- METC142070
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