NCT00893230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

1.8 years

First QC Date

May 4, 2009

Last Update Submit

May 4, 2009

Conditions

Atopic Dermatitis

Keywords

atopic dermatitischemokinesprobiotics

Outcome Measures

Primary Outcomes (1)

  • SCORAD score

    12 weeks

Secondary Outcomes (1)

  • Chemokine levels

    12 weeks

Study Arms (2)

Lactobacillus sakei KCTC 10755BP

EXPERIMENTAL
Dietary Supplement: probiotic L sakei KCTC 10755BP

microcrystalline cellulose

PLACEBO COMPARATOR
Dietary Supplement: microcrystalline cellulose (placebo)

Interventions

probiotic L sakei KCTC 10755BPDIETARY_SUPPLEMENT

freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

Lactobacillus sakei KCTC 10755BP
microcrystalline cellulose (placebo)DIETARY_SUPPLEMENT

freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks

microcrystalline cellulose

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • a total SCORAD score above 25
  • a change in a total SCORAD score of not more than 10% within 2 weeks

You may not qualify if:

  • patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, 361-711, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Youn-Soo Hahn, MD, PhD

    Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 5, 2009

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

KR(1)