此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Functional Dyspepsia and Symptom Perception

2015年8月12日更新者：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.

研究概览

地位

未知

条件

消化不良

研究类型

观察性的

注册 (预期的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

荷兰
- - Maastricht、荷兰、6202 AZ
    - 招聘中
    - Maastricht University Medical Center (MUMC+)
    - 接触：
      
      Annick Alleleyn, MD
      
      电话号码：+31433884190
      
      邮箱：a.alleleyn@maastrichtuniversity.nl
    - 接触：
      
      Fabiënne Smeets, MD
      
      邮箱：fabienne.smeets@maastrichtuniversity.nl
    - 首席研究员：
      
      Jose Conchillo, MD PhD
  - Sittard-Geleen、荷兰
    - 尚未招聘
    - Zuyderland Medical Center
    - 接触：
      
      Annick Alleleyn, MD
      
      电话号码：+31433884190
      
      邮箱：a.alleleyn@maastrichtuniversity.nl
    - 接触：
      
      Fabiënne Smeets, MD
      
      邮箱：fabienne.smeets@maastrichtuniversity.nl
  - Tilburg、荷兰
    - 尚未招聘
    - St. Elisabeth Medical Center
    - 接触：
      
      Annick Alleleyn, MD
      
      电话号码：+31433884190
      
      邮箱：a.alleleyn@maastrichtuniversity.nl
    - 接触：
      
      Fabiënne Smeets, MD
      
      邮箱：fabienne.smeets@maastrichtuniversity.nl

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
健康控制
Patients with functional dyspepsia

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
TRPV-1 neuropeptide pathway (TRPV-1 and mucosal neuropeptides) 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Symptom scores for psychopathology 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Maastricht University Medical Center

调查人员

首席研究员：Jose Conchillo, MD, PhD、Maastricht University Medical Center, Maastricht, The Netherlands

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年7月1日

初级完成 (预期的)

2017年7月1日

研究完成 (预期的)

2017年7月1日

研究注册日期

首次提交

2015年7月29日

首先提交符合 QC 标准的

2015年8月12日

首次发布 (估计)

2015年8月13日

研究记录更新

最后更新发布 (估计)