A Study of a Probiotic in Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: probiotic L sakei KCTC 10755BP; Dietary Supplement: microcrystalline cellulose (placebo)

• Registration Number: NCT00893230
• Lead Sponsor: Chungbuk National University

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-05
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Last Update Submitted: 2009-05-04
• Study First Posted: 2009-05-05
• Last Update Posted: 2009-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus sakei KCTC 10755BP	probiotic L sakei KCTC 10755BP	-
microcrystalline cellulose	microcrystalline cellulose (placebo)	-

Primary Outcome Measures

Name	Time	Method
SCORAD score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Chemokine levels	12 weeks

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of