the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: ATP mixed probiotics
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under the 2 years old, 36 children Mild to moderate atopic dermatitis with cow milk allergy Volunteers who agreed by their parents. The severity of their disease was assessed by modified SCORAD index Exclusion Criteria: Severe atopic dermatitis Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks Anaphylaxis, Angioedema, or severe allergic reaction to the cow milk Chronic diarrhea

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br>* - 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<br>* Other names: DUOLAC;|
| Placebo Comparator: Group B<br>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. | Drug: Placebo<br>* - 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<br>* Other names: DUOLAC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 weeks after patient recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 weeks after wash-out period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Food allergy, Probiotics