A Study of a Probiotic in Atopic Dermatitis - Full Text View

Sponsors and Collaborators:	Chungbuk National University Department of Applied Microbiology, Yeungnam University,Korea Korean Research Institute of Bioscience and Biotechnology,Korea Departments of Pediatrics,Gachon University of Medicine and Science,Korea
Information provided by:	Chungbuk National University
ClinicalTrials.gov Identifier:	NCT00893230

Purpose

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

Condition	Intervention	Phase
Atopic Dermatitis	Dietary Supplement: probiotic L sakei KCTC 10755BP Dietary Supplement: microcrystalline cellulose (placebo)	Phase III

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Cellulose sodium phosphate Cellulose Phosphocellulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers

Further study details as provided by Chungbuk National University:

Primary Outcome Measures:

SCORAD score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chemokine levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	88
Study Start Date:	January 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lactobacillus sakei KCTC 10755BP: Experimental	Dietary Supplement: probiotic L sakei KCTC 10755BP freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
microcrystalline cellulose: Placebo Comparator	Dietary Supplement: microcrystalline cellulose (placebo) freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	2 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893230

Locations

Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of, 361-711

Sponsors and Collaborators

Chungbuk National University

Department of Applied Microbiology, Yeungnam University,Korea

Korean Research Institute of Bioscience and Biotechnology,Korea

Departments of Pediatrics,Gachon University of Medicine and Science,Korea

Investigators

Principal Investigator:

Youn-Soo Hahn, MD, PhD

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

More Information

No publications provided

Responsible Party:	Department of Pediatrics, College of Medicine, Chungbuk National University, Korea ( Youn-Soo Hahn )
Study ID Numbers:	CS 7403-179
Study First Received:	May 4, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00893230 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chungbuk National University:

atopic dermatitis
chemokines
probiotics

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009