Probiotic Bacteria to Infants With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01007331
First received: November 3, 2009
Last updated: February 16, 2010
Last verified: November 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunoglobulin E (IgE) Total [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Immunoglobulin E (IgE) specific for Egg [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Immunoglobulin E (IgE) specific for Milk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Interleukin-10 (Il-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Interleukin-12 (Il-12) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Interferon gamma (IFN-gamma) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Calprotectin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Polymerase Chain Reaction (PCR) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Eosinophil Cation Protein (ECP) [ Time Frame: 7 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atopic dermatitis

Exclusion Criteria:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 3, 2009
Last Updated: February 16, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014