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the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

S

Soon Chun Hyang University

Status

Withdrawn

Conditions

Atopic Dermatitis

Treatments

Drug: ATP mixed probiotics
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01045486
schprobiotics

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

6 months to 2 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

36 participants in 2 patient groups, including a placebo group

Group A
Active Comparator group
Description:
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.
Treatment:
Drug: ATP mixed probiotics
Group B
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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