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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Atopic Dermatitis
Drug: ATP mixed probiotics
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

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 [ Time Frame: 6 weeks after patient recruitment ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 6 weeks after wash-out period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: January 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   6 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045486

Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Study Chair: Bok Yang Pyun Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital, Pediatric Allergy & Respiratory Center, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01045486     History of Changes
Other Study ID Numbers: schprobiotics
Study First Received: January 8, 2010
Last Updated: July 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Soonchunhyang University Hospital:
Atopic dermatitis
Food allergy
Probiotics

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Milk Hypersensitivity
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Food Hypersensitivity

ClinicalTrials.gov processed this record on April 17, 2014