Back to resultsA Study of a Probiotic in Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
probiotic L sakei KCTC 10755BP
microcrystalline cellulose (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, chemokines, probiotics
Eligibility 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
Sites / Locations
- Chungbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lactobacillus sakei KCTC 10755BP
microcrystalline cellulose
Arm Description
Outcomes
Primary Outcome Measures
SCORAD score
Secondary Outcome Measures
Chemokine levels
Full Information
NCT ID
NCT00893230
First Posted
May 4, 2009
Last Updated
May 4, 2009
Sponsor
Chungbuk National University
Collaborators
Yeungnam University Hospital, Korea Research Institute of Bioscience & Biotechnology, Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00893230
Brief Title
A Study of a Probiotic in Atopic Dermatitis
Official Title
A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chungbuk National University
Collaborators
Yeungnam University Hospital, Korea Research Institute of Bioscience & Biotechnology, Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, chemokines, probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus sakei KCTC 10755BP
Arm Type
Experimental
Arm Title
microcrystalline cellulose
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic L sakei KCTC 10755BP
Intervention Description
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
microcrystalline cellulose (placebo)
Intervention Description
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
Primary Outcome Measure Information:
Title
SCORAD score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Chemokine levels
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn-Soo Hahn, MD, PhD
Organizational Affiliation
Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
361-711
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study of a Probiotic in Atopic Dermatitis
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