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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00893230

Enrollment

Registered

2009-05-05

Start date

2007-01-31

Completion date

2008-11-30

Last updated

2009-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, chemokines, probiotics

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.

Interventions

DIETARY_SUPPLEMENTprobiotic L sakei KCTC 10755BP

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

DIETARY_SUPPLEMENTmicrocrystalline cellulose (placebo)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

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

Design outcomes

Primary

Measure	Time frame
SCORAD score	12 weeks

Secondary

Measure	Time frame
Chemokine levels	12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026