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临床试验/EUCTR2012-004354-28-DK
EUCTR2012-004354-28-DK进行中(未招募)1 期

Maintenance treatment in childhood constipation.A randomized placebo-controlled intervention study

Børneafdelingen Kolding0 个研究点开始时间: 2013年7月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Referred children to the pediatric out patient clinic with either constipation or fecal incontinence, age 2 to 16 years.
  • Children must meet the ROME III criteria. This means that children below 4 years must meet at least 2 of the following criteria during a month, children above 4 years must meet at least 2 of the criteria at least once a week for 2 months:
  • Two or fewer bowel movements weekly.
  • More than one episode of fecal incontinence weekly.
  • Painful defecation.
  • Occasional passage of large stools.
  • Display of retentive posturing and withholding behavior.
  • Large stools in the rectum identified by digital examination or palpable on abdominal examination.
  • Rome III criteria is developed by scientists and widely internationally accepted among research in childhood constipation.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 125
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Children not eligible for participation is children who receive treatment with medications known to affect bowel function, apart from laxatives, within a 2-month period and children e.g. with known organic causes of constipation including Hirschsprung disease, previous surgery on the colon or inflammatory bowel disease.

研究者

发起方
Børneafdelingen Kolding

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