A Study of a Probiotic in Atopic Dermatitis

May 4, 2009 updated by: Chungbuk National University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju, Korea, Republic of, 361-711
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: microcrystalline cellulose
Dietary supplement: microcrystalline cellulose (placebo)
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SCORAD score
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Chemokine levels
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungbuk National University

Collaborators

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

Investigators

  • Principal Investigator: Youn-Soo Hahn, MD, PhD, Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS 7403-179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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