A Study of a Probiotic in Atopic Dermatitis

NCT ID: NCT00893230

Last Updated: 2009-05-05

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-11-30

Brief Summary

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The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.

Detailed Description

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Probiotics were also shown to reduce severity of AEDS when administered to infants with early onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established AEDS. In these studies, administration of Lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S aureus growth among Lactobacillus species in our preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide a more objective evidence for the beneficial role of this probiotic.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lactobacillus sakei KCTC 10755BP

Group Type EXPERIMENTAL

probiotic L sakei KCTC 10755BP

Intervention Type DIETARY_SUPPLEMENT

freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

microcrystalline cellulose (placebo)

Intervention Type DIETARY_SUPPLEMENT

freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

Interventions

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probiotic L sakei KCTC 10755BP

freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

microcrystalline cellulose (placebo)

freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* patients with atopic dermatitis present for at least 6 months before inclusion
* a total SCORAD score above 25
* a change in a total SCORAD score of not more than 10% within 2 weeks

Exclusion Criteria

* patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University Hospital

OTHER

Sponsor Role collaborator

Korea Research Institute of Bioscience & Biotechnology

OTHER_GOV

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role collaborator

Chungbuk National University

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics, College of Medicine, Chungbuk National University, Korea

Principal Investigators

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Youn-Soo Hahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CS 7403-179

Identifier Type: -

Identifier Source: org_study_id

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