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A Study of a Probiotic in Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893230
First Posted: May 5, 2009
Last Update Posted: May 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Yeungnam University Hospital
Korea Research Institute of Bioscience & Biotechnology
Gachon University Gil Medical Center
Information provided by:
Chungbuk National University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Chungbuk National University:

Primary Outcome Measures:
  • SCORAD score [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Chemokine levels [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893230


Locations
Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of, 361-711
Sponsors and Collaborators
Chungbuk National University
Yeungnam University Hospital
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

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
First Submitted: May 4, 2009
First Posted: May 5, 2009
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by Chungbuk National University:
atopic dermatitis
chemokines
probiotics

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