Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Functional Dyspepsia and Symptom Perception

12 sierpnia 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Niestrawność

Typ studiów

Obserwacyjny

Zapisy (Oczekiwany)

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Holandia
- - Maastricht, Holandia, 6202 AZ
    - Rekrutacyjny
    - Maastricht University Medical Center (MUMC+)
    - Kontakt:
      
      Annick Alleleyn, MD
      
      Numer telefonu: +31433884190
      
      E-mail: a.alleleyn@maastrichtuniversity.nl
    - Kontakt:
      
      Fabiënne Smeets, MD
      
      E-mail: fabienne.smeets@maastrichtuniversity.nl
    - Główny śledczy:
      
      Jose Conchillo, MD PhD
  - Sittard-Geleen, Holandia
    - Jeszcze nie rekrutacja
    - Zuyderland Medical Center
    - Kontakt:
      
      Annick Alleleyn, MD
      
      Numer telefonu: +31433884190
      
      E-mail: a.alleleyn@maastrichtuniversity.nl
    - Kontakt:
      
      Fabiënne Smeets, MD
      
      E-mail: fabienne.smeets@maastrichtuniversity.nl
  - Tilburg, Holandia
    - Jeszcze nie rekrutacja
    - St. Elisabeth Medical Center
    - Kontakt:
      
      Annick Alleleyn, MD
      
      Numer telefonu: +31433884190
      
      E-mail: a.alleleyn@maastrichtuniversity.nl
    - Kontakt:
      
      Fabiënne Smeets, MD
      
      E-mail: fabienne.smeets@maastrichtuniversity.nl

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
Zdrowe kontrole
Patients with functional dyspepsia

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides) Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Symptom scores for psychopathology Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Maastricht University Medical Center

Śledczy

Główny śledczy: Jose Conchillo, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2015

Zakończenie podstawowe (Oczekiwany)

1 lipca 2017

Ukończenie studiów (Oczekiwany)