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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01045486

Enrollment

Registered

2010-01-11

Start date

2010-01-31

Completion date

2010-09-30

Last updated

2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, Food allergy, Probiotics

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.

Interventions

DRUGATP 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

DRUGPlacebo

\- 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 2 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026