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Trial record 67 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Effect of Oral Magnesium Therapy on Constipation on Cerebral Palsy Children

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ClinicalTrials.gov Identifier: NCT03471312
Recruitment Status : Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
NAMostafa, Assiut University

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.

Condition or disease Intervention/treatment
Magnesium Therapy on Cerebral Palsy Patients 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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Oral Magnesium Therapy on Constipation on Children With Cerebral Palsy
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

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 Name: placebo

treated with placebo drug
will receive placebo drug
Drug: Magnesium
magnesium therapy
Other Name: placebo




Primary Outcome Measures :
  1. EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE [ Time Frame: 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


Secondary Outcome Measures :
  1. Evaluate the main side effect of oral magnesium therapy (Diarrhea) [ Time Frame: baseline ]
    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



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes 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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471312


Contacts
Contact: Nermeen abdelmageed 01145325756 ext 00+20 nemo.memo19.nm@gmail.com
Contact: ahlam badawi ahlam3badawi@med.au.edu.eg

Sponsors and Collaborators
Assiut University

Responsible Party: NAMostafa, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03471312     History of Changes
Other Study ID Numbers: constipation on cp patients
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Constipation
Cerebral Palsy
Signs and Symptoms, Digestive
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases