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Intestinal Permeability in Children/Adolescents With Functional Dyspepsia

2020年12月16日 更新者:Children's Mercy Hospital Kansas City

Intestinal Permeability and Serum Zonulin Concentration in Children/Adolescents With Functional Dyspepsia

The main purpose of this study is to evaluate whether intestinal permeability and/or serum zonulin concentration is increased in children/adolescents with functional dyspepsia (FD). The study will also explore the relationships between intestinal permeability, mucosal inflammation and anxiety in FD patients.

研究概览

地位

完全的

详细说明

Recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. It represents the most common chronic pain entity in pediatric patients. The great majority of these patients will have a functional gastrointestinal disorder (FGID). The most common FGID in these patients is functional dyspepsia (FD), defined as upper abdominal pain or discomfort unrelieved by bowel movement and in the absence of a structural or biochemical explanation for the pain. The etiology of FD is multifactorial, including biological factors, and these factors can be viewed within a biopsychosocial model. Biological factors include inflammation, dysmotility and increased visceral sensitivity. These biological factors are influenced by and are interactive with psychosocial factors such as anxiety, depression and social interaction. This study will evaluate intestinal permeability as a measure of barrier dysfunction and investigate the correlations between increased permeability, mucosal inflammation and anxiety scores to provide further insight into the etiology of FD, thereby assisting in the development and selection of treatment modalities.

研究类型

观察性的

注册 (实际的)

42

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

    • Missouri
      • Kansas City、Missouri、美国、64108
        • The Children's Mercy Hospital and Clinics

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

8年 至 17年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Children with chronic abdominal pain.

描述

Inclusion Criteria:

  • abdominal pain of at least 8 weeks duration and fulfilling Rome II symptom based criteria for functional dyspepsia (patient group only);
  • undergoing endoscopy to evaluate FD following demonstration of a lack of clinical response to standard acid reduction therapy (patient group only); and,
  • informed permission/assent

Exclusion Criteria:

  • previous abdominal surgery;
  • any chronic non-gastrointestinal illness requiring regular medical care (e.g. diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer);
  • any history of an adverse reaction to lactulose or mannitol;
  • any use of antacids or laxatives within 1 week prior to the study;
  • any use of steroids, antihistamines or antihistamine-like drugs within 4 weeks prior to the study;
  • any use of aspirin is prohibited within one week prior to the study;
  • any use of non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin is restricted within one week prior to the study or at the discretion of the Study Physician;
  • any use of antibiotics including neomycin (Mycifradin) within 4 weeks prior to the study;
  • pregnancy;
  • any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation (healthy control group only); or
  • non-English speaking

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

研究衡量的是什么?

主要结果指标

结果测量
大体时间
differential sugar absorption test, serum zonulin
大体时间:5 hour urine collection after administration of test article, serum collected during study visit
5 hour urine collection after administration of test article, serum collected during study visit

次要结果测量

结果测量
大体时间
Behavioral Assessment Scale for Children (BASC) anxiety scores
大体时间:collected during study visit
collected during study visit
T-lymphocyte, eosinophil and mast cell densities on duodenal biopsy samples
大体时间:collected during biopsy, patient group only
collected during biopsy, patient group only

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。

调查人员

  • 首席研究员:Craig A. Friesen, MD、The Children's Mercy Hospital and Clinics

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2006年8月1日

初级完成 (实际的)

2010年7月1日

研究完成 (实际的)

2010年7月1日

研究注册日期

首次提交

2006年8月11日

首先提交符合 QC 标准的

2006年8月11日

首次发布 (估计)

2006年8月15日

研究记录更新

最后更新发布 (实际的)

2020年12月19日

上次提交的符合 QC 标准的更新

2020年12月16日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 0606-104

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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