Constipation is a common problem in children. There is some clinical evidence for the role of probiotics in the treatment of constipated children. This study is about the therapeutic effect of synbiotic (combination of probiotic and prebiotic) in treatment of childhood constipation. In a double-blind randomized placebo controlled study (RCTs) 102 children, aged 4–12 years, with functional constipation according to Rome III criteria were assessed for 4 weeks. They were randomized in 3 groups: Group A received 1.5 ml/kg/day oral liquid paraffin plus placebo, group B received 1 sachet of synbiotic per day plus placebo and group C received 1.5 ml/kg/day oral liquid paraffin plus 1 sachet of synbiotic per day. Frequency of bowel movements (BMs), stool consistency, number of fecal incontinence episodes, abdominal pain, painful defecation per week, success treatment, and side effects determined in each group before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811193309N1
Registration date:2010-04-20, 1389/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-20, 1389/01/31
Registrant information
Name
Mozhgan Sabbaghian
Name of organization / entity
Department of Gastroenterology, Children's Medical Center Hospital, Tehran University of Medical Sc
Country
Iran (Islamic Republic of)
Phone
+98 26 1442 1904
Email address
sabbaghian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-01, 1388/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Role of Synbiotic in the Treatment of Childhood Constipation
Public title
The Role of Synbiotic in the Treatment of Childhood Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 4-12 years, diagnosis based on Room III criteria as two months of at least 2 or more of the following: less than 2 defecation in the toilet per week, more than 1 episode of fecal incontinence per week, history of retentive posturing or excessive volitional stool retention, history of painful or hard bowel movements, presence of a large fecal mass in the rectum, history of large diameter stools that may obstruct the toilet.
Exclusion criteria: presence of organic causes for constipation; including Hirschsprung’s disease, spina bifida occulta, hypothyroidism, cystic fibrosis, neurologic abnormalities and intestinal pseudo-obstruction
Age
From 4 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Tehran University of Medical Sciences
Street address
Tehran University of Medical Science, 16 Azar St.
City
Tehran
Postal code
Approval date
2010-02-08, 1388/11/19
Ethics committee reference number
88/ S /130/1771
Health conditions studied
1
Description of health condition studied
Other diseases of intestines
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Frequency of bowel movements per week
Timepoint
4 weeks
Method of measurement
Questionnarie
2
Description
Stool consistency
Timepoint
4 Weeks
Method of measurement
Questionnarie
3
Description
Frequency of stool incontinence per week
Timepoint
4 Weeks
Method of measurement
questionnarie
4
Description
Abdominal pain
Timepoint
4 weeks
Method of measurement
questionnarie
5
Description
Painful defecation
Timepoint
4 weeks
Method of measurement
Questionnarie
Secondary outcomes
1
Description
Success treatment
Timepoint
4 weeks
Method of measurement
Success treatment defined as ≥ 3 Bowel Movements per week,≤ 2 incontinence per month and no abdominal pain
2
Description
Adverse effects
Timepoint
4 weeks
Method of measurement
Questionnarie
Intervention groups
1
Description
1.5 ml/kg/day oral liquid paraffin plus placebo (placebo sachet with the same shape and color to synbiotic)
Category
Treatment - Drugs
2
Description
1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and Fructooligosaccharide as prebiotic) and placebo (with the same shape and color to paraffin oil)
Category
Treatment - Drugs
3
Description
1.5 ml/kg/day oral liquid paraffin and 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and Fructooligosaccharide as prebiotic)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Mozhgan Sabbaghian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mozhgan Sabbaghin
Street address
Department of Gastroenterology, Children Medical Center Hospital, Tehran University of Medical Science
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
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
Full name of responsible person
Dr. Manijh Khalili
Position
Fellowship of gastroentrlogy
Other areas of specialty/work
Street address
Department of Gastroenterology, Children's Medical Center Hospital, Tehran University of Medical Science
City
Tehran تهران
Postal code
Phone
+98 21 2213 0265
Fax
Email
dr_khalili2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Khodadad
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Gastroenterology, Children's Medical Center Hospital, Tehran University of Medical Science مرکز طبی کودکان
City
Tehran
Postal code
Phone
+98 21 6692 4545
Fax
Email
khodadadmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Sabbaghian
Position
Felowship
Other areas of specialty/work
Street address
Department of Gastroenterology, Children Medical Center Hospital, Tehran University of Medical Science
City
Tehran
Postal code
Phone
+98 26 1442 1904
Fax
Email
mozhgan_sabbaghian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)