Back to resultsthe Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
Primary Purpose
Atopic Dermatitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ATP mixed probiotics
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Food allergy, Probiotics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
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 received placebo medication for 6 weeks followed by a crossover to 6 weeks of active medication (ATP mixed probiotics) after 4-weeks washout period.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01045486
First Posted
January 8, 2010
Last Updated
July 20, 2011
Sponsor
Soonchunhyang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01045486
Brief Title
the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
failed to enroll patients
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Soonchunhyang University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Food allergy, Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ATP mixed probiotics
Other Intervention Name(s)
DUOLAC
Intervention Description
- 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
DUOLAC
Intervention Description
- 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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bok Yang Pyun
Organizational Affiliation
Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
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