the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

NCT ID: NCT01045486

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

ATP mixed probiotics

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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DUOLAC DUOLAC

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pediatric Allergy & Respiratory Center, Soonchunhyang University Hospital

Principal Investigators

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Bok Yang Pyun

Role: STUDY_CHAIR

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

Other Identifiers

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schprobiotics

Identifier Type: -

Identifier Source: org_study_id

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