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临床试验/NCT01078064
NCT01078064终止不适用

Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
NUMBER OF REFLUX EPISODES

研究概览

简要总结

Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.

详细描述

Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.

This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD* symptoms

排除标准

  • continuous feeding
  • previous fundoplication

结局指标

主要结局

NUMBER OF REFLUX EPISODES

时间窗: 1 day

It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study

次要结局

  • Gastric volume ratio: 10 min/baseline(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Strehl Machado

MD, PhD

Nationwide Children's Hospital

研究点 (1)

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