The pourpose of this study is the effect of probiotic in the treatment of functional constipation in 4– 12 years old children . Methods: A single- blind randomized controlled study (RCT)was performed. 90 children aged 4- 12 years old with functional constipation according to rome III criteria were assessed for 4 weeks.They were randomized in 2 groups: Group A received 0.7-1.5gr⁄kg ⁄day powder pydrolax per day. Group B: 2 sachet of probiotic plus 0.7-1.5gr⁄ kg ⁄day powder pydrolax. Frequency of bowel movements (BMs), stool consistency, number of fecal incontinence episodes, abdominal pain, painful defecation per week, side effects were analyzed in each group before treatment and 2 and 4 weeks after institution of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041513021N1
Registration date:2014-05-09, 1393/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-09, 1393/02/19
Registrant information
Name
Banafshe Sedaghat
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 4646
Email address
bani.2010@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy of Pidrolax powder and Probiotic in the treatment of functional constipation in 4– 12 years old children
Public title
The effect of Probiotics in the treatment of functional constipation in 4– 12 years old children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 4-12 years old children; functional constipation[to rome III criteria], Exclusion criteria:consumption of laxative during last 4 weeks; mental retardation; hypothyroidism; cystic fibrosis and previous intestinal surgery.
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Beast Farmer Street Hospital in Sanandaj
City
Sanandaj
Postal code
66177-13446
Approval date
2012-11-15, 1391/08/25
Ethics committee reference number
Paragraph 10 No. 14/28626 second meeting of Medical Ethics
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
k59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Less than 3 times defecation per week
Timepoint
Before intervention and 2 and 4 weeks after institution of intervention