- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02522000
Functional Dyspepsia and Symptom Perception
Symptom Perception in Patients With Functional Dyspepsia: Involvement of the TRPV-1 Neuropeptide Pathway
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Annick Alleleyn, MD
- Telefonní číslo: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
Studijní záloha kontaktů
- Jméno: Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
Studijní místa
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Maastricht, Holandsko, 6202 AZ
- Nábor
- Maastricht University Medical Center (MUMC+)
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Kontakt:
- Annick Alleleyn, MD
- Telefonní číslo: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
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Kontakt:
- Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
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Vrchní vyšetřovatel:
- Jose Conchillo, MD PhD
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Sittard-Geleen, Holandsko
- Zatím nenabíráme
- Zuyderland Medical Center
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Kontakt:
- Annick Alleleyn, MD
- Telefonní číslo: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
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Kontakt:
- Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
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Tilburg, Holandsko
- Zatím nenabíráme
- St. Elisabeth Medical Center
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Kontakt:
- Annick Alleleyn, MD
- Telefonní číslo: +31433884190
- E-mail: a.alleleyn@maastrichtuniversity.nl
-
Kontakt:
- Fabiënne Smeets, MD
- E-mail: fabienne.smeets@maastrichtuniversity.nl
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Zdravé kontroly
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Patients with functional dyspepsia
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Symptom scores for psychopathology
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jose Conchillo, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- METC142070
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