Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 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
- 是
入选标准
- •applicable to all participants:
- •Children between 7-17 years of age where permission is granted for the participation by habitable parents with custody of the child. In case of joint custody, permission must be obtained from both parents.
- •Inclusion criteria applicable only to healthy participants:
- •Gastrointestinal healthy children without chronic constipation
- •Inclusion criteria applicable only to constipated participants:
- •Chronic constipation defined by Rom IV criteria, which is a diagnostic score for chronic constipation
- •Inclusion criteria applicable only to children in vincristine treatment:
- •Children with cancer in treatment with vincristine
- •Inclusion criteria applicable only to patients with NF1:
- •Diagnosis of NF1 with gastrointestinal symptoms
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
研究组 & 干预措施
Children being investigated with 3D-transit
4 groups of each 20 children will be investigated with respectively one or two capsules:
- Healthy children (1)
- Children with chronic constipation (2)
- Children with neurofibromatosis type 1 (2)
- Children with cancer receiving treatment with Vincristine (1)
干预措施: 3D-Transit (Diagnostic Test)
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