Comparison of two treatment regimens of
powders and syrup of polyethylene glycol
40% in the treatment of chronic functional
constipation in children under 15 years
The aim of this study was to compare the efficacy of a treatment regimen powder and liquid polyethylene glycol %40 polyethylene glycol in the treatment of chronic constipation in children is functional. This study is a single-blind clinical trial., 96 patients with chronic constipation problem referred to Children's Clinic . Inclusion criteria: history of large-diameter stools; Record keeping stool. Exclusion criteria: children with organic constipation; Obstructive abnormality or anorectal anorectal surgery; ROME III criteria identify children who have irritable bowel syndrome; Children over 2 weeks before entering the study received treatment for constipation; Children with mental retardation or metabolic diseases such as hypothyroidism; Children with Hirschsprung's disease or spinal cord anomalies or anorectal pathology. The children selected by convenience sampling and randomly placed in two groups. The first group will receive polyethylene glycol powder and the second group syrup of 40% polyethylene glycol for two months. At the end of the study, children who are considered constipation treatment has been improved
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120415530N3
Registration date:2015-12-27, 1394/10/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Karamali Kasiri
Name of organization / entity
Shahrekord University of Medical sciences.
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
kasiri@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University Of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two treatment regimens of
powders and syrup of polyethylene glycol
40% in the treatment of chronic functional
constipation in children under 15 years
Public title
Comparison of two treatment regimens of
powders and syrup of polyethylene glycol
40% in the treatment of chronic functional
constipation in children under 15 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of large-diameter stools; Record keeping stools Exclusion criteria: children with organic constipation; Obstructive abnormality or anorectal anorectal surgery; ROME III criteria identify children who have irritable bowel syndrome; Children over 2 weeks before entering the study received treatment for constipation; Children with mental retardation or metabolic diseases such as hypothyroidism; Children with Hirschsprung's disease or spinal cord anomalies or pathology anorectal
Age
To 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2015-08-30, 1394/06/08
Ethics committee reference number
IR.Skums.REC.1394.91
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
conctipation
Primary outcomes
1
Description
defication
Timepoint
two months
Method of measurement
chek list
Secondary outcomes
empty
Intervention groups
1
Description
The first group polyethylene glycol powder orally for 70 grams in a liter of water, grams per kilogram of body weight will receive daily for a period of two weeks .
Category
Treatment - Drugs
2
Description
The second group polyethylene glycol 40% in edible syrup for 2/5 cc kg of body weight daily will receive for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar hospital
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Solati Kamal
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Pediatricians, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
kasiri@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
karamali kasiri
Position
Pediatricians, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord , Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
kasiri@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Pediatricians, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
kasiri@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)