Determination of the effect of polyethylene glycol powder and lactolose syrup in children with constipation
Design
Randomized, unblinded, uncontrolled clinical trial with parallel groups
Settings and conduct
Children with chronic functional constipation referring to Hajar hospital in Shahrekord were randomly divided into two groups of 47 each.One group received polyethylene glycol and the other received lactulose. Fecal excretion, fecal incontinence, painful excretion, abdominal pain, as well as fecal consistency were recorded in a checklist before the intervention and 7, 14, and 21 days after the intervention. Painless excretion of stool with smooth or normal consistency at least three times a week is defined as success of treatment .
ّFirst intervention group received polyethylene glycol (Darupakhsh Pharmaceutical Co.) 3 gr (for children of 6 months or less) or 6 gr (for children of above 6 months) orally in three divided doses daily for 4 weeks. Second intervention group received lactulose (Darupakhsh Pharmaceutical Co.) 6 cc (for children of 6 months or less) and 12 cc (for children of above 6 months) orally in three divided doses daily for 4 weeks.
Main outcome variables
constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044239N1
Registration date:2019-11-08, 1398/08/17
Registration timing:registered_while_recruiting
Last update:2019-11-08, 1398/08/17
Update count:0
Registration date
2019-11-08, 1398/08/17
Registrant information
Name
Karamali Kasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
kasiri.k@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of polyethylene glycol and lactulose in children with constipation
Public title
The effect of polyethylene glycol and lactulose in children with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic functional constipation
Exclusion criteria:
Ileus
Renal failure
Heart failure
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of the participants to the intervention 1 and 2 groups will be done using random allocation software. Then, envelopes prepare according to the number of participants in the study. It will be recorded number one on the first envelope, the second envelope number 2, and etc. In each envelope, the assignment of each individual is determined by the software. In this way, the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention 1 and/or intervention 2 groups according to the option recorded in the envelope.
Blinding (investigator's opinion)
Not 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
Vice Chancellor of Research and Technology , Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718765
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.SKUMS.REC.1398.074
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.00
ICD-10 code description
Constipation, unspecified
Primary outcomes
1
Description
constipation
Timepoint
Before the intervention and after 7, 14 and 21 days
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group received polyethylene glycol (Darupakhsh Pharmaceutical Co.) 3 gr (for children of 6 months or less) or 6 gr (for children of above 6 months) orally in three divided doses daily for 4 weeks.
Category
Treatment - Drugs
2
Description
intervention group 2: This group received lactulose (Darupakhsh Pharmaceutical Co.) 6 cc (for children of 6 months or less) and 12 cc (for children of above 6 months) orally in three divided doses daily for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Karamali Kasiri
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8819819854
Phone
+98 38 3222 0016
Email
kasiri.k@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Kamal Solati
Street address
Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881954525
Phone
+98 38 3334 2414
Email
solati@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718761
Phone
+98 32220016
Email
kasiri.k@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718761
Phone
+98 38 3222 0016
Email
kasiri.k@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Karamali Kasiri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718761
Phone
+98 32220016
Email
karamali.k@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
checklist information
When the data will become available and for how long
after data gathering
To whom data/document is available
Researchers
Under which criteria data/document could be used
publication of article
From where data/document is obtainable
Dr. Karamali Kasiri
What processes are involved for a request to access data/document