Effect of Oral Magnesium Therapy on Constipation on Cerebral Palsy Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Magnesium Therapy on Cerebral Palsy Patients
• Intervention / Treatment: Drug: Magnesium

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cerebral palsy patients in the neuro pediatric unit, at Assiut University Children's Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
treated with magnesium therapy; will receive magnesium sulphate 10 mg \kg \day as a single oral dose for one month duration	Drug: Magnesium; magnesium therapy; Other Names: placebo
treated with placebo drug; will receive placebo drug	Drug: Magnesium; magnesium therapy; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE	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	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the main side effect of oral magnesium therapy (Diarrhea)	Evaluate the main side effect of oral magnesium therapy (Diarrhea) on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at assiut university hospital by a questionnaire asking about amount , frequency and nature of stool	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2018
• Primary Completion (ANTICIPATED): October 30, 2018
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: March 10, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (ACTUAL): March 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Signs and Symptoms, Digestive; Cerebral Palsy; Constipation
• Other Study ID Numbers: constipation on cp patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No