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Functional Dyspepsia and Symptom Perception

12 augusti 2015 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Studietyp

Observationell

Inskrivning (Förväntat)

70

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Friska kontroller
Patients with functional dyspepsia

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Symptom scores for psychopathology
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Maastricht University Medical Center

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2015

Primärt slutförande (Förväntat)

1 juli 2017

Avslutad studie (Förväntat)

1 juli 2017

Studieregistreringsdatum

Först inskickad

29 juli 2015

Först inskickad som uppfyllde QC-kriterierna

12 augusti 2015

Första postat (Uppskatta)

13 augusti 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 augusti 2015

Senast verifierad

1 juli 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • METC142070

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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