The Impact of Dietary Fiber Intervention on Constipation in Neurologically Impaired Children.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups
研究概览
简要总结
The current increasing survival of children with central nervous system damage has created a major challenge for medical care. Gastrointestinal and nutritional problems in neurologically impaired children have been recognized as an integral part of their disease, often leading to growth failure and worsened quality of life for both children and caregivers. (1) Measuring rectal wall thickness to highlight the benefit of dietary intervention to constipated children having neurological impairment will be a novel point in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 2 years to 14 years
- •Patients with upper motor neuronal lesion confirmed by MRI , who are following at Neurology clinic for at least 6 months before enrollment.
- •Those suffering from constipation according to Rome IV criteria as the presence of the following two or more symptoms for at least 3 months, with symptom onset at least 6 months prior to diagnosis: having two or fewer defecations per week, history of excessive stool retention, history of painful or hard bowel movements, history of large-diameter stools that may obstruct the toilet, presence of a large fecal mass in the rectum and at least one episode per week of incontinence after the acquisition of toileting skills.
排除标准
- •Patients with constipation and have any comorbidities contributing to constipation ex: hypothyroidism, diabetes mellitus, cow milk protein allergy (CMPA) and anorectal deformities.
- •Patient following any certain regimen due to inborn errors of metabolism and those who underwent any gastrointestinal tract (GIT) surgeries as resection anastomosis.
- •Patients on ketogenic diet as line of managing epilepsy.
结局指标
主要结局
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups
时间窗: 3 to 6 months
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups will be used as a objective method of assessing constipation in those patients
To decrease the incidence of constipation in children with neurological impairment as well as improve bowel function.
时间窗: 3 to 6 months
Aim of the primary outcome is to decrease the incidence of constipation in children with neurological impairment and improve bowel function by using same methods referred to in study design and methodology
次要结局
未报告次要终点