the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

Not Applicable

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Drug: ATP mixed probiotics; Drug: Placebo

• Registration Number: NCT01045486
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	ATP mixed probiotics	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.
Group B	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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