Effect of Oral Magnesium Therapy on Constipation on Cerebral Palsy Children

NCT ID: NCT03471312

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-12-30

Brief Summary

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.

Detailed Description

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.

• 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.

Conditions

Magnesium Therapy on Cerebral Palsy Patients

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

treated with magnesium therapy

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

Magnesium

Intervention Type: DRUG

magnesium therapy

treated with placebo drug

will receive placebo drug

Magnesium

Intervention Type: DRUG

magnesium therapy

Interventions

Magnesium

magnesium therapy

Intervention Type: DRUG

Other Intervention Names

placebo

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed as cerebral palsy

2. Age below18 year

3. Presence of constipation according to ROME criteria

Exclusion Criteria

1. Patients with cardiac problem

2. Patients with renal problem

3. Patients with GIT problem or chronic diarrhea

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

NAMostafa

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nermeen abdelmageed

Role: CONTACT

nemo.memo19.nm@gmail.com

01145325756 ext. 00+20

ahlam badawi

Role: CONTACT

ahlam3badawi@med.au.edu.eg

Other Identifiers

constipation on cp patients

Identifier Type: -

Identifier Source: org_study_id