A Study of a Probiotic in Atopic Dermatitis

Chungbuk National University

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: probiotic L sakei KCTC 10755BP; Dietary Supplement: microcrystalline cellulose (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT00893230

CS 7403-179

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

88 participants in 2 patient groups, including a placebo group

Lactobacillus sakei KCTC 10755BP

Experimental group

Treatment:

Dietary Supplement: probiotic L sakei KCTC 10755BP

microcrystalline cellulose

Placebo Comparator group

Treatment:

Dietary Supplement: microcrystalline cellulose (placebo)