Trial | NCT00893230  Report issue

Title

A Study of a Probiotic in Atopic Dermatitis
A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    88
The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.
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.
Study Started
Jan 31
2007
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Last Update
May 05
2009
Estimate

Dietary Supplement probiotic L sakei KCTC 10755BP

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

Dietary Supplement microcrystalline cellulose (placebo)

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

Lactobacillus sakei KCTC 10755BP Experimental

microcrystalline cellulose Placebo Comparator

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
No Results Posted