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Probiotic Bacteria to Infants With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atopic Dermatitis focused on measuring Infants, Atopic Dermatitis, SCORAD, IgE, Eosinophil Cation Protein, Calprotectin, Intestinal microflora

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Atopic dermatitis

Exclusion Criteria:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication

Sites / Locations

  • Institute of Human Nutrition

Outcomes

Primary Outcome Measures

Scoring atopic dermatitis (SCORAD) index

Secondary Outcome Measures

Immunoglobulin E (IgE) Total
Immunoglobulin E (IgE) specific for Egg
Immunoglobulin E (IgE) specific for Milk
Interleukin-10 (Il-10)
Interleukin-12 (Il-12)
Interferon gamma (IFN-gamma)
Calprotectin
Polymerase Chain Reaction (PCR)
Eosinophil Cation Protein (ECP)

Full Information

First Posted
November 3, 2009
Last Updated
February 16, 2010
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01007331
Brief Title
Probiotic Bacteria to Infants With Atopic Dermatitis
Official Title
Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The aim of the study is to investigate whether two different probiotics influence the clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the immunologic status and the intestinal microflora, inflammation and permeability will also be investigated. Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups receiving either Lactobacillus acidophilus NCFM (1x10^10 Colony forming units), Bifidobacterium lactis Bi-07(1x10^10 Colony forming units) or placebo every day for 8 weeks. At the beginning and at the end of the study the following analyses will be made: SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms. Blood samples will be drawn to examine: Immunoglobulin E (IgE), total and specific for egg and milk. Eosinophil Cation Protein (ECP) Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma) Fecal samples will be collected to examine: Calprotectin (intestinal inflammation) Bacterial Deoxyribonucleic acid (DNA) will be extracted in order to perform Polymerase chain reaction (PCR) analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Infants, Atopic Dermatitis, SCORAD, IgE, Eosinophil Cation Protein, Calprotectin, Intestinal microflora

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
Intervention Description
10^10 colony forming units pr day of probiotics
Primary Outcome Measure Information:
Title
Scoring atopic dermatitis (SCORAD) index
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Immunoglobulin E (IgE) Total
Time Frame
6 months
Title
Immunoglobulin E (IgE) specific for Egg
Time Frame
6 months
Title
Immunoglobulin E (IgE) specific for Milk
Time Frame
6 months
Title
Interleukin-10 (Il-10)
Time Frame
6 months
Title
Interleukin-12 (Il-12)
Time Frame
6 months
Title
Interferon gamma (IFN-gamma)
Time Frame
6 months
Title
Calprotectin
Time Frame
one year
Title
Polymerase Chain Reaction (PCR)
Time Frame
8 months
Title
Eosinophil Cation Protein (ECP)
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atopic dermatitis Exclusion Criteria: Chronic diseases other than atopic dermatitis Chronic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim F Michaelsen, Professor
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Human Nutrition
City
Rolighedsvej 30
State/Province
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

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Probiotic Bacteria to Infants With Atopic Dermatitis

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