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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 |
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Information provided by: | Chungbuk National University |
ClinicalTrials.gov Identifier: | NCT00893230 |
The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.
Condition | Intervention | Phase |
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Atopic Dermatitis |
Dietary Supplement: probiotic L sakei KCTC 10755BP Dietary Supplement: microcrystalline cellulose (placebo) |
Phase III |
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 |
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 |
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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
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microcrystalline cellulose: Placebo Comparator |
Dietary Supplement: microcrystalline cellulose (placebo)
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
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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.
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Chungbuk National University Hospital | |
Cheongju, Korea, Republic of, 361-711 |
Principal Investigator: | Youn-Soo Hahn, MD, PhD | Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea, |
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 |
atopic dermatitis chemokines probiotics |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Hypersensitivity Dermatitis, Atopic Immune System Diseases Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |