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临床试验/NCT01695915
NCT01695915已完成不适用

Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.

Line Modin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Rectal diameter

研究概览

简要总结

The purpose of the study is to determine the diurnal variation of rectal diameter in healthy and constipated children using transabdominal ultrasound.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month.

排除标准

  • Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
  • Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives.
  • Healthy inclusion Criteria:
  • Children between 4 and 12 years of age.
  • Healthy exclusion Criteria:
  • Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
  • Children receiving drugs known to affect bowel function during a 2 month period before initiation.
  • Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.

结局指标

主要结局

Rectal diameter

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
Line Modin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Line Modin

Medical doctor

Vejle Hospital

研究点 (1)

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