A Study of a Probiotic in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893230
• Other study ID #: CS 7403-179
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2009
• Last updated: May 4, 2009
• Start date: January 2007
• Est. completion date: November 2008

Study information

• Verified date: May 2009
• Source: Chungbuk National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• probiotic L sakei KCTC 10755BP
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
• microcrystalline cellulose (placebo)
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju

Sponsors (4)

Lead Sponsor	Collaborator
Chungbuk National University	Gachon University Gil Medical Center, Korea Research Institute of Bioscience & Biotechnology, Yeungnam University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD score		12 weeks	No
Secondary	Chemokine levels		12 weeks	No