the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01045486
• Other study ID #: schprobiotics
• Status: Withdrawn
• Phase: N/A
• First received: January 8, 2010
• Last updated: July 20, 2011
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 36
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 2 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Milk Hypersensitivity

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-?, TGF-ß, TNF-a, and IgG4) after drug administration		6 weeks after patient recruitment	Yes
Secondary	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-?, TGF-ß, TNF-a, and IgG4) after drug administration		6 weeks after wash-out period	Yes