This study compares the effects drug therapy and behavioral therapy techniques such as toilet training to the children suffering from functional constipation. In this study, 100 children with the diagnosis of functional constipation, referred to Gastroenterology Clinic of Aliasghar Hospital will be assigned to receive drug treatment (Lactulose 1 gram/kilogram and a teaspoonful senagol) or behavioral therapy (sitting for 10 to 15 minutes in the toilet after each meal). Total suppository use, use of laxatives, Soiling underwear, the rate of painful defecation, going to the toilet and complications during treatment will be recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012275479N1
Registration date:2011-02-21, 1389/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-21, 1389/12/02
Registrant information
Name
Tahereh Parvini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2041
Email address
drparvini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ali asghar hospital, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2010-06-24, 1389/04/03
Expected recruitment end date
2011-07-09, 1390/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effects of toilet training in the treatment of functional constipation in children
Public title
Determination of the effects of toilet training in the treatment of functional constipation in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children between 3- 12
Exclusion criteria: age less than 3 and more than 12, any causes of disability, physical or mental, any systemic diseases
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Hemmat Highway, Next to the Milad Tower
City
Tehran
Postal code
Approval date
2010-10-24, 1389/08/02
Ethics committee reference number
896/1
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
change in bowel habit NOS
Primary outcomes
1
Description
Go to the toilet
Timepoint
daily
Method of measurement
Questionnaire
2
Description
The rate of painful defecation
Timepoint
daily
Method of measurement
Questionnaire
3
Description
Underwear soiling
Timepoint
daily
Method of measurement
Questionnaire
4
Description
Use of laxatives
Timepoint
daily
Method of measurement
Questionnaire
5
Description
Total suppository use
Timepoint
daily
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Senagol 1 gram per KG Lactolose 1 teaspoonful for four months
Category
Treatment - Drugs
2
Description
Behavioral therapy including: 10 to 15 minutes remaining in toilet for four months
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali asghar hospital
Full name of responsible person
Dr. Nakhaei
Street address
Zafar st., North modarres highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Otukesh
Street address
North modarres highway - Ali asghar hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Tahereh Parvini
Position
Pediatric Resident
Other areas of specialty/work
Street address
Tehran University of Medical Sciences and Health Services - Tehran
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
+98 21 2222 2044
Email
drparvini@razi.tums.ac.ir
Web page address
Tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahrbanoo Nakhaee
Position
Assistant Professor
Other areas of specialty/work
Street address
Ali asghar hospital
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
+98 21 2222 2044
Email
moshiri@techstp.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Tahereh Parvini
Position
Pediatrics resident
Other areas of specialty/work
Street address
Ali asghar hospital
City
Ttehran
Postal code
Phone
+98 21 2222 2041
Fax
+98 21 2222 2044
Email
drparvini@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)