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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01045486
First Posted: January 11, 2010
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soonchunhyang University Hospital
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 8, 2010
First Posted: January 11, 2010
Last Update Posted: July 21, 2011
Last Verified: July 2011

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

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