A Study of a Probiotic in Atopic Dermatitis

Study Overview
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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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of NFM proBio65 in the Atopic and Allergic Volunteers

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: probiotic L sakei KCTC 10755BP
* Dietary Supplement: microcrystalline cellulose (placebo)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus sakei KCTC 10755BP<br> | Dietary Supplement: probiotic L sakei KCTC 10755BP<br>* freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks<br>|
| Placebo Comparator: microcrystalline cellulose<br> | Dietary Supplement: microcrystalline cellulose (placebo)<br>* freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemokine levels |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, chemokines, probiotics