the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
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|ClinicalTrials.gov Identifier: NCT01045486|
Recruitment Status : Withdrawn (failed to enroll patients)
First Posted : January 11, 2010
Last Update Posted : July 21, 2011
There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice.
The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: ATP mixed probiotics Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||September 2010|
Active Comparator: Group A
Group A received active medication (ATP mixed probiotics) for 6 weeks followed by a crossover to 6 weeks of placebo after 4-weeks washout period.
Drug: ATP mixed probiotics
- Patients in Group A will receive ATP mixed probiotics for 6 weeks. And after 4 weeks wash-out period, they will receive placebo for 6 weeks
Other Name: DUOLAC
Placebo Comparator: Group B
Group B received placebo medication for 6 weeks followed by a crossover to 6 weeks of active medication (ATP mixed probiotics) after 4-weeks washout period.
- Patients in Group B will receive placebo for 6 weeks. And after 4 weeks wash-out period, they will receive ATP mixed probiotics for 6 weeks
Other Name: DUOLAC
- Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration [ Time Frame: 6 weeks after patient recruitment ]
- Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration [ Time Frame: 6 weeks after wash-out period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045486
|Study Chair:||Bok Yang Pyun||Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital|