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临床试验/NCT03471312
NCT03471312Unknown不适用

Effect of Oral Magnesium Therapy on Constipation on Children With Cerebral Palsy

Assiut University0 个研究点目标入组 50 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE

研究概览

简要总结

The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.

详细描述

Children with cerebral palsy (CP) often experience many comorbidities such as constipation,which is considered a frequent problem in spastic (cp)children .It occurs due to reduced mobility, difficulties in feeding and as a side effect of many muscle relaxing medications.It is estimated that 74% of children with cerebral palsy suffer from constipation ,which necessitates use of laxatives. Magnesium sulfate has a famous role as being an osmotic laxative,which is the first step in the pharmacological treatment of constipation

• Mechanism of action of mg sulphate: They are poorly absorbed by the intestinal wall, which leads to intraluminal accumulation of hyperosmolar particles. This stimulates retention of water in the intestinal lumen, softening the stools and increasing peristalsis through intestinal distension. It acts by accelerating small intestinal transit both in fasting and in fed state and it tends to increase the frequency and weight of stools, compared with placebo.In addition ,It increases intraluminal secretion of cholecystokinin and increases nitric oxide (NO) release.

• Side effects of mg sulphate: Reducing the intestinal absorption of fat, protein and carbohydrates following solid meal ingestion

• other drugs used as laxative in cp and there side effects:

  • Lactulose: it can lead to distention, bloating and excess flatus. In some individuals these side-effects may limit the use of this product.
  • Glycerin: is another small molecule that can exert osmotic activity in the colon. It is not absorbed by the colon and is used as a suppository to draw water into the rectum to produce a bowel movement. It is well absorbed by the small intestine, and hence cannot be taken by oral route.

研究设计

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

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as cerebral palsy
  • Age below18 year
  • Presence of constipation according to ROME criteria

排除标准

  • Patients with cardiac problem
  • Patients with renal problem
  • Patients with GIT problem or chronic diarrhea

研究组 & 干预措施

treated with magnesium therapy

will receive magnesium sulphate 10 mg \kg \day as a single oral dose for one month duration

干预措施: Magnesium (Drug)

treated with placebo drug

will receive placebo drug

干预措施: Magnesium (Drug)

结局指标

主要结局

EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE

时间窗: baseline

Evaluate the effect of oral magnesium therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at assiut university hospital by comparison of the percentage of improving cases in the 2 groups (first group using oral magnesium therapy . second group using placebo) by a questionnaire asking about amount , frequency and nature of stool

次要结局

  • Evaluate the main side effect of oral magnesium therapy (Diarrhea)(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NAMostafa

principal investigator

Assiut University

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