Probiotic Bacteria to Infants With Atopic Dermatitis

February 16, 2010 updated by: University of Copenhagen

Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.

  2. 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)

  3. 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

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

  • Denmark
    • Frederiksberg C
      • Rolighedsvej 30, Frederiksberg C, Denmark, 1958
        • Institute of Human Nutrition

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

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Atopic dermatitis

Exclusion Criteria:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scoring atopic dermatitis (SCORAD) index
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunoglobulin E (IgE) Total
Time Frame: 6 months
6 months
Immunoglobulin E (IgE) specific for Egg
Time Frame: 6 months
6 months
Immunoglobulin E (IgE) specific for Milk
Time Frame: 6 months
6 months
Interleukin-10 (Il-10)
Time Frame: 6 months
6 months
Interleukin-12 (Il-12)
Time Frame: 6 months
6 months
Interferon gamma (IFN-gamma)
Time Frame: 6 months
6 months
Calprotectin
Time Frame: one year
one year
Polymerase Chain Reaction (PCR)
Time Frame: 8 months
8 months
Eosinophil Cation Protein (ECP)
Time Frame: 7 months
7 months

Collaborators and Investigators

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

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Kim F Michaelsen, Professor, Department of Human Nutrition, University of Copenhagen

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

November 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (ESTIMATE)

November 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 16, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-D200 Probørn

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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