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A Study of a Probiotic in Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborators:
Yeungnam University
Korea Research Institute of Bioscience & Biotechnology
Gachon University Gil Medical Center
Information provided by:
Chungbuk National University
ClinicalTrials.gov Identifier:
NCT00893230
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
 Dietary Supplement: probiotic L sakei KCTC 10755BP
Dietary Supplement: microcrystalline cellulose (placebo)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chungbuk National University:

Primary Outcome Measures:
  • SCORAD score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chemokine levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus sakei KCTC 10755BP Dietary Supplement: probiotic L sakei KCTC 10755BP
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
Placebo Comparator: microcrystalline cellulose Dietary Supplement: microcrystalline cellulose (placebo)
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893230

Locations
Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of, 361-711
Sponsors and Collaborators
Chungbuk National University
Yeungnam University
Korea Research Institute of Bioscience & Biotechnology
Gachon University Gil Medical Center
Investigators
Principal Investigator: Youn-Soo Hahn, MD, PhD Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,
  More Information

No publications provided

Responsible Party: Youn-Soo Hahn, Department of Pediatrics, College of Medicine, Chungbuk National University, Korea
ClinicalTrials.gov Identifier: NCT00893230     History of Changes
Other Study ID Numbers: CS 7403-179
Study First Received: May 4, 2009
Last Updated: May 4, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chungbuk National University:
atopic dermatitis
chemokines
probiotics

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013