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Functional Dyspepsia and Symptom Perception

12 августа 2015 г. обновлено: 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.

Обзор исследования

Статус

Неизвестный

Условия

Диспепсия

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Нидерланды
- - Maastricht, Нидерланды, 6202 AZ
    - Рекрутинг
    - Maastricht University Medical Center (MUMC+)
    - Контакт:
      
      Annick Alleleyn, MD
      
      Номер телефона: +31433884190
      
      Электронная почта: a.alleleyn@maastrichtuniversity.nl
    - Контакт:
      
      Fabiënne Smeets, MD
      
      Электронная почта: fabienne.smeets@maastrichtuniversity.nl
    - Главный следователь:
      
      Jose Conchillo, MD PhD
  - Sittard-Geleen, Нидерланды
    - Еще не набирают
    - Zuyderland Medical Center
    - Контакт:
      
      Annick Alleleyn, MD
      
      Номер телефона: +31433884190
      
      Электронная почта: a.alleleyn@maastrichtuniversity.nl
    - Контакт:
      
      Fabiënne Smeets, MD
      
      Электронная почта: fabienne.smeets@maastrichtuniversity.nl
  - Tilburg, Нидерланды
    - Еще не набирают
    - St. Elisabeth Medical Center
    - Контакт:
      
      Annick Alleleyn, MD
      
      Номер телефона: +31433884190
      
      Электронная почта: a.alleleyn@maastrichtuniversity.nl
    - Контакт:
      
      Fabiënne Smeets, MD
      
      Электронная почта: fabienne.smeets@maastrichtuniversity.nl

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

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

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Здоровые элементы управления
Patients with functional dyspepsia

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides) Временное ограничение: 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

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Symptom scores for psychopathology Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Maastricht University Medical Center

Следователи

Главный следователь: Jose Conchillo, MD, PhD, Maastricht University Medical Center, Maastricht, The Netherlands

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2015 г.

Первичное завершение (Ожидаемый)

1 июля 2017 г.

Завершение исследования (Ожидаемый)