The main objective of this study was to determine whether consumption of prebiotics can reduce the severity of AD in 7-24 month old children in Isfahan. In a double blind controlled trial study seventy 7-24 months old full term children with Atopic Dermatitis (AD), delivered by cesarean section, with no other chronic diseases, not treated with corticosteroid or any other immunosuppressive drugs, were randomly assigned into 2 groups. The intervention group received prebiotic (fructooligosaccharide + inulin) and the control group received placebo (dextrin powder) for 3 months. At the baseline and the end of the intervention SCORAD test questionnaire was completed for all children by a physician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809072779N1
Registration date:2010-02-16, 1388/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-16, 1388/11/27
Registrant information
Name
Fereydoun Siassi
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4924
Email address
siassif@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2008-03-21, 1387/01/02
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of prebiotic in atopic dermatitis reduction in 7-24 months old children living in Isfahan
Public title
Effectiveness of prebiotic in atopic dermatitis reduction in 7-24 months old children living in Isfahan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 7-24 months old children with atopic dermatitis (AD); full term with normal weight at birth; delivered by cesarean, weaning food started after 6 months; willingness of the parents for participation in the trial.
Exclusion criteria: Treatment with corticosteroid or any immunosuppressive drugs during the last 3 months prior to the trial; having any chronic diseases except AD.
Age
From 1 year old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Vice Chancellor for Research, Ethical Clearance Approval, Tehran University of Medical Sciences and
Street address
Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
empty
Ethics committee reference number
130/1429
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.8
ICD-10 code description
Other Atopic dermatitis
Primary outcomes
1
Description
Severity of atopic dermatitis
Timepoint
Monthly
Method of measurement
SCORAD (SCOring Atopic Dermatitis)
Secondary outcomes
empty
Intervention groups
1
Description
Control: 0.8g maltodextrin (placebo) per 100 ml consuming milk for 3 months.
Category
Treatment - Drugs
2
Description
Intervention: 0.8g fructo-oligosaccharides + inulin mixture (prebiotic) per 100 ml consuming milk for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Children Clinic of Al_Zahra Hospital in Isfahan
Full name of responsible person
Dr. Fariborz Zandieh
Street address
Department of Pediatrics of AlZahra Hospital, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Under Secretary of Research, Tehran University of Medical Sciences and Health Services (TUMS)
Full name of responsible person
D. Akbar Fotouhi, Undersecretary of Research, TUMS