the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

NCT01045486 | Withdrawn DMC

• 1 other identifier: schprobiotics
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Food allergy; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

PLACEBO COMPARATOR

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

Interventions

ATP mixed probiotics DRUG

\- 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

Also known as: DUOLAC

Group A

Placebo DRUG

\- 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

Also known as: DUOLAC

Group B

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bok Yang Pyun

  Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 21, 2011

Record last verified: 2011-07