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Functional Dyspepsia and Symptom Perception

12. srpna 2015 aktualizováno: 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.

Přehled studie

Postavení

Neznámý

Podmínky

Typ studie

Pozorovací

Zápis (Očekávaný)

70

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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

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

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Zdravé kontroly
Patients with functional dyspepsia

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Symptom scores for psychopathology
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
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.
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
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.
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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jose Conchillo, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2015

Primární dokončení (Očekávaný)

1. července 2017

Dokončení studie (Očekávaný)

1. července 2017

Termíny zápisu do studia

První předloženo

29. července 2015

První předloženo, které splnilo kritéria kontroly kvality

12. srpna 2015

První zveřejněno (Odhad)

13. srpna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

13. srpna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. srpna 2015

Naposledy ověřeno

1. července 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • METC142070

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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