In a randomized, double-blind, placebo-controlled study, 40 infants and children aged 3months to 6 years with mild to severe AD will receive either a mixture of 7 probiotic strains or placebo for 8 weeks. The Severity Scoring of Atopic Dermatitis (SCORAD) will recorded at baseline and also at 4 and 8 weeks of treatment.IL-4 and IFN-gamma concentrations will be assessed on the supernatant after polyclonal stimulation of mononuclear cells culture
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010204976N1
Registration date:2011-02-09, 1389/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-09, 1389/11/20
Registrant information
Name
Hamid Ahanchian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
ahanchianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Mashhad University of medical sciences
Expected recruitment start date
2007-02-02, 1385/11/13
Expected recruitment end date
2009-02-02, 1387/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a new synbiotic mixture on atopic dermatitis
in children
Public title
Synbiotic in Atopic Dermatitis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
Aged from 3 months to 6 years
Mild to severe Atopic dermatitis
Exclusion:
Prior exposure to probiotics
Were currently taking a course of antibiotics,
or had other major medical problems
At the beginning of the study, 2 months after intervention
Method of measurement
SCORAD method
Secondary outcomes
1
Description
Cytokine profile(IL-4, INF- Gamma )
Timepoint
At the beginning of the study, 2 months after intervention
Method of measurement
ELISA on supernatant of Blood lymphocyte culture
Intervention groups
1
Description
Participants were randomly divided into two groups.
Intervention: Patients in the probiotic group received synbiotic containing 1 billion Colony Forming Unit(CFU) of Protexin Restore: a mixture of Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus and Fructooligosaccharide (Protexin healthcare, Somerset, United Kingdom), in the form of freeze dried powder twice daily for 8 weeks.
Category
Treatment - Drugs
2
Description
CONTROL: The control group received placebo powder without probiotics which were matched for size, shape, and volume of contents and manufactured by the same company, twice daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Hamid Ahanchian
Street address
Pediatric Allergy department, Ghaem hospital, Ahmad Abad Blvd, Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Mashhad University of medical sciences.