Determination of the effectiveness of polyethylene glycol syrup in comparison with lactulose syrup in children with chronic functional constipation
Design
A double-blind clinical trial was performed on 100 children aged 1 to 15 years randomly divided into two groups of 50 patients. Each group was randomly assigned to polyethylene glycol and lactulose syrup.
Settings and conduct
A double-blind clinical trial was performed on 100 children with chronic functional constipation aged 1 to 15 years randomly divided into two groups of 50 patients. Each group was randomly assigned to polyethylene glycol and lactulose syrup.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with chronic functional constipation aged between 1-and 15 years old.
Exclusion criteria: Children with chronic functional constipation aged between 1-and 15 years old with organic reasons.
Intervention groups
Group 1:groups A treated with lactulose syrup
Group 2:groups B treated with polyethylene glycol syrup
Main outcome variables
Daily number of deification.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036783N2
Registration date:2022-09-05, 1401/06/14
Registration timing:retrospective
Last update:2022-09-05, 1401/06/14
Update count:0
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
Naghi Dara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 9003
Email address
drdara49@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of polyethylene glycol syrup and lactulose syrup in children aged 1 to 15 years with chronic functional constipation
Public title
Comparison of the effect of polyethylene glycol syrup and lactulose syrup in children aged 1 to 15 years with chronic functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-15 years old
Chronic Functional Constipation
Exclusion criteria:
others causes of constipation
Age
From 1 year old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be examined by a gastroenterologist and rejecting the organic causes of constipation. Then will be randomly divided into two groups A and B based on randomly table.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was performed as a double-blind clinical trial on 100 children aged 1 to 15 years old randomly divided into two groups of 50 patients. After random allocation of patients, the investigator will be assigned to each of the medicines A and B, and the treatment will be followed by the patient or the referring person according to the chosen code.
The syrup prepared from both of the two drugs will be quite similar in shape, taste and other factors.Therefore, the doctor and the patients will not be aware of the blindness process.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti university of medical science
weekly in the first month then monthly for 3 months.
Method of measurement
bristol stool chart
Secondary outcomes
1
Description
Daily number of soft defecation.
Timepoint
The time periods of measurement to evaluate the number of stools will be visited weekly for one month and then monthly for three months by a gastroenterologist.
Method of measurement
A researcher-made checklist will be used to evaluate the number of bowel movements. For this purpose, the checklist will be provided to the parents.
2
Description
quality of daily defecation
Timepoint
The time periods of measurement to evaluate the quality of stool consistency based on the Bristol chart will be visited weekly for one month and then monthly for three months by a gastroenterologist.
Method of measurement
In order to evaluate the quality and consistency of stool, a researcher's checklist based on the Bristol chart will be used. For this purpose, the checklist will be provided to the parents.
Intervention groups
1
Description
Intervention group 1: In this group, polyethylene glycol syrup with a concentration of 60 percent with the same dose of 1 milligram per kilogram daily is prescribed in three divided doses after meals.
Category
Treatment - Drugs
2
Description
intervention group 2: In this group, lactose syrup with the same dose of 1 milligram per kilogram daily is administered in three doses after meals.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of the effect of polyethylene glycol syrup and lactulose syrup in children aged 1 to 15 years with chronic functional constipation referred to gastroenterology clinic of Mofid Hospital
When the data will become available and for how long
6 month after data gathering
To whom data/document is available
All of the researcher aimed at data analyzing.
Under which criteria data/document could be used
For analyzing and using in the researchs.
From where data/document is obtainable
dr. Naghi Dara
What processes are involved for a request to access data/document
Sending request via email or presence.
The requesting person's authentication and ensuring the purpose of the research.
Sending the data via email or presence within 10 days.