To evaluate the efficacy of probiotics compared to paraffin for treatment of chronic constipation in pediatric population aged between 2-16 years,60 children between 2-16 years who have chronic constipation will be randomly assigned.First group received 1.5 grams per kilogram of body weight of Parrafin and Pidrolax and second group received Pidrolax and probiotics.
Symptoms evaluated by physician at baseline,4th week and 8th week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409015330N7
Registration date:2014-11-27, 1393/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-27, 1393/09/06
Registrant information
Name
Mandana Rafeey
Name of organization / entity
Liver and gastrointestinal research center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 4135
Email address
rafieem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
VICE-CHANCELLOR FOR RESEARCH OF TABRIZ UNIVERSITY OF MEDICAL SCIENCES
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-09-20, 1393/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of probiotics in treatment of chronic constipation in children
Public title
Effect of probiotics in children constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include:
History of childhood constipation ; Ranged in age from 2 to 16 years
Exclusion criteria include:
There is an organic cause for constipation; A drug that affects the bowel movements; Obstruction or stenosis of the gastrointestinal tract; Lack of consent to continue the study for any reason; The drug intolerant or intolerable side effects for the patient
Age
From 1 year old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
blindness for control and interventional group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences, Golgasht Av, Tabriz
City
Tabriz
Postal code
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
5/4/4668
Health conditions studied
1
Description of health condition studied
Chronic constipation in children
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Defecation frequency more than 3 times in a week and stool consistency
Timepoint
Baseline, week 4, week 8
Method of measurement
Clinical Evaluation
Secondary outcomes
1
Description
Faecal incontinence episodes less than one time in a week
Timepoint
Baseline, week 4 , week 8
Method of measurement
Clinical Evaluation
Intervention groups
1
Description
Control group: receive 1.5 grams per kilogram of body weight Parrafin and Pidrolax
Category
Treatment - Drugs
2
Description
Interventional group: receive probiotics and Pidrolax
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz children Hospital
Full name of responsible person
Dr Mandana Rafeey
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
VICE-CHANCELLOR FOR RESEARCH OF TABRIZ UNIVERSITY OF MEDICAL SCIENCES
Full name of responsible person
Farzaneh Fakhimaliakbari
Street address
Children Hospital, Sheshgelan, Tabriz
City
Tabriz
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 OF TABRIZ 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
Tabriz university of medical sciences
Full name of responsible person
Dr Mandana Rafeey
Position
professor
Other areas of specialty/work
Street address
Children Hospital, Shishgalan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3526 2250
Fax
Email
mrafeey@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Mandana Rafeey
Position
Proffesor of pediatric gastroentrology
Other areas of specialty/work
Street address
Children hospital, Shishgalan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3526 2250
Fax
Email
mrafeey@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Farzaneh Fakhimaliakbari
Position
Resident
Other areas of specialty/work
Street address
Children Hospital, Shishgalan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3526 2250
Fax
Email
farzanehfakhim@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)