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Probiotic Bacteria to Infants With Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007331
First Posted: November 4, 2009
Last Update Posted: February 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Copenhagen
  Purpose
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.

Condition Intervention
Atopic Dermatitis Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Scoring atopic dermatitis (SCORAD) index [ Time Frame: 5 months ]

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

Enrollment: 62
Study Start Date: November 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
    10^10 colony forming units pr day of probiotics
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atopic dermatitis

Exclusion Criteria:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007331


Locations
Denmark
Institute of Human Nutrition
Rolighedsvej 30, Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Kim F Michaelsen, Professor Department of Human Nutrition, University of Copenhagen
  More Information

Responsible Party: Kim Fleischer Michaelsen, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01007331     History of Changes
Other Study ID Numbers: KF-D200 Probørn
First Submitted: November 3, 2009
First Posted: November 4, 2009
Last Update Posted: February 17, 2010
Last Verified: November 2009

Keywords provided by University of Copenhagen:
Infants
Atopic Dermatitis
SCORAD
IgE
Eosinophil Cation Protein
Calprotectin
Intestinal microflora

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases