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临床试验/NCT03981510
NCT03981510Unknown不适用

Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

University of Aarhus2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年6月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
The investigation is without discomfort and adverse events.

研究概览

简要总结

To gain a better understanding of the underlying dysmotility in constipation in children, we will use a novel minimal invasive method called 3D Transit. We will examine four groups of children aged 7 to 17 years: healthy children, chronically constipated children (ROM IV criteria), children with neurofibromatosis type 1 and finally children receiving chemotherapy (vincristin) for acute lymphoblastic leukemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Children with parents who are unable to understand the given particpant's information
  • Children with known dysregulated metabolic disease
  • Previously major intra-abdominal surgery
  • CNS surgery
  • Other treatment-requiring gastrointestinal disorder
  • Systemic steroid treatment within the last week
  • Children with difficulty swallowing
  • Children with known gastrointestinal obstruction or perforation
  • Acute infections
  • Diagnosed malabsorption including bile acid malabsorption
  • Menarche in girls

结局指标

主要结局

The investigation is without discomfort and adverse events.

时间窗: 3 days

Children in Vincristine treatment has a longer transit time through the colon and fewer fast bowel movements than healthy children.

时间窗: 3 days

Children with NF1 and gastrointestinal symptoms has a longer transit time through the colon and fewer fast bowel movements than healthy children.

时间窗: 3 days

Children with chronic constipation has a longer transit time through the colon and fewer fast bowel movements than healthy children.

时间窗: 3 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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