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the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

This study has been withdrawn prior to enrollment.
(failed to enroll patients)
Sponsor:
Information provided by:
Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01045486
First received: January 8, 2010
Last updated: July 20, 2011
Last verified: July 2011

January 8, 2010
July 20, 2011
January 2010
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01045486 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • 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
  • Drug: Placebo
    - 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
  • 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.
    Intervention: Drug: ATP mixed probiotics
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
36
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
6 Months to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01045486
schprobiotics
Yes
Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital, Pediatric Allergy & Respiratory Center, Soonchunhyang University Hospital
Soonchunhyang University Hospital
Not Provided
Study Chair: Bok Yang Pyun Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Soonchunhyang University Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP