In this randomized double blind-placebo controlled trial we aimed to evaluate the effect of synbiotic supplementation in treatment of childhood atopic dermatitis (AD). We recruited children aged 1–36months with moderate to severe Atopic Dermatitis (SCORAD>25). Exclusion criteria were age less than 1 month and more than 36 months, SCORAD<25,and primery chronic disease. Infants were randomized (n=40) and received either Synbiotic (Probiotic plus Prebiotic) (n=20) or placebo (n=20) daily as a powder for two months. Emollient (Eucerin) and topical corticosteroid (Hydrocortisone) were permitted to use daily as a routin treatment of atopic dermatitis in both intervention and control groups. Children were scored for severity of atopic dermatitis (SCORAD)at the beginig and end of study as primary out com meseare
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009094719N2
Registration date:2010-12-20, 1389/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-20, 1389/09/29
Registrant information
Name
Alireza Shafiei
Name of organization / entity
Iranian Asthma Allergy and Immunology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 7772 2452
Email address
shafii@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Asthma Allergy and Immunology Research Institu
Expected recruitment start date
2007-01-01, 1385/10/11
Expected recruitment end date
2008-01-01, 1386/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of synbiotics in reduction scoring of childhood atopic dermatitis (SCORAD)
Public title
Effect of synbiotics in treatment of childhood atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were children aged 1–36months with moderate to severe Atopic Dermatitis (SCORAD>25). Exclusion criteria were age less than 1 month and more than 36 months, SCORAD<25, recurrent infections( as an evidence of immunodeficiency), congenital abnormality, chronic disease and problem in eating and administration of systemic corticosteroids.
Age
To 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Iranian Asthma Allergy and Immunology Ethics Committee
Street address
Children Medical Center Hospital ,Gharib Street
City
Tehran
Postal code
Approval date
2008-11-04, 1387/08/14
Ethics committee reference number
238/پ/412
Health conditions studied
1
Description of health condition studied
atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Dermatitis and eczema
Primary outcomes
1
Description
sevearity of atopic dermatitis acording to SCORAD
Timepoint
befor and two months after intervention
Method of measurement
SCORAD table
Secondary outcomes
1
Description
adverse reaction
Timepoint
every 2 weeks
Method of measurement
asking from parents
Intervention groups
1
Description
In the intrvention group, children daily took one sachet containing 10 milligram mixture of 1 × 109 CFU/ of seven strain probiotics plus prebiotic (990 milligram fructo-oligosaccharides). We instructed usual treatment of atopic dermatitis including bathing with lukewarm water, moisturing cream (Eucerin) and topical corticosteroid (Hydrocortisone 1%) once time, daily for two month in intervention group
Category
Treatment - Drugs
2
Description
In the control group, children daily took one sachet for oral use ,containing 1000 milligram sucrose. similarly We instructed usual treatment of atopic dermatitis including bathing with lukewarm water, moisturing cream (Eucerin) and topical corticosteroid (Hydrocortisone 1%) once time, daily for two month in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
chidren medical center hospital,allergy ward
Full name of responsible person
alireza shafiei
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Astاma Allergy and Immunology Research Institu
Full name of responsible person
Mostafa Moin
Street address
Chidren Medical Center Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Astاma Allergy and Immunology Research Institu
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
Masood Movahedi
Position
Assistant Professor
Other areas of specialty/work
Street address
Allergy Ward,Chidren Medical Center Hospital, Gharib Street
City
Tehran
Postal code
Phone
+98 66938545
Fax
Email
movahedm@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Masood Movahedi
Position
Assistant Professor
Other areas of specialty/work
Street address
Allergy Ward, Chidren Medical Center Hospital, Gharib Street
City
Tehran
Postal code
Phone
+98 66938545
Fax
Email
movahedm@sina.tums.ac.ir
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
Masood Movahedi
Position
Assistant Professor
Other areas of specialty/work
Street address
Allergy ward,Children Medical Center Hospital, Ghareeb Street
City
Tehran
Postal code
Phone
+98 66938545
Fax
Email
movahedm@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)