NCT01007331

Brief Summary

The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
Last Updated

February 17, 2010

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

November 3, 2009

Last Update Submit

February 16, 2010

Conditions

Atopic Dermatitis

Keywords

InfantsAtopic DermatitisSCORADIgEEosinophil Cation ProteinCalprotectinIntestinal microflora

Outcome Measures

Primary Outcomes (1)

  • Scoring atopic dermatitis (SCORAD) index

    5 months

Secondary Outcomes (9)

  • Immunoglobulin E (IgE) Total

    6 months

  • Immunoglobulin E (IgE) specific for Egg

    6 months

  • Immunoglobulin E (IgE) specific for Milk

    6 months

  • Interleukin-10 (Il-10)

    6 months

  • Interleukin-12 (Il-12)

    6 months

  • +4 more secondary outcomes

Interventions

Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07BEHAVIORAL

10\^10 colony forming units pr day of probiotics

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Atopic dermatitis

You may not qualify if:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition

Rolighedsvej 30, Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

  • Kim F Michaelsen, Professor

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

November 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 17, 2010

Record last verified: 2009-11

Locations

DK(1)