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Completed

NCT Number: NCT00893230

A Study of a Probiotic in Atopic Dermatitis

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chungbuk National University Hospital

Cheongju-si, 361-711, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

probiotic L sakei KCTC 10755BP

Dietary Supplement

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

Microcrystalline Cellulose (placebo)

Dietary Supplement

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

Primary outcomes

  1. SCORAD score

    Time frame: 12 weeks

Secondary outcomes

  1. Chemokine levels

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Chungbuk National University

Other

Collaborators

  • Gachon University Gil Medical Center
  • Korea Research Institute of Bioscience & Biotechnology
  • Yeungnam University Hospital

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 5, 2009
Registry last updated
May 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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