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

November 3, 2009
February 16, 2010
November 2006
July 2008   (final data collection date for primary outcome measure)
Scoring atopic dermatitis (SCORAD) index [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • SCORAD
  • IgE
  • IL-10
  • IL-12
  • IFN-gamma
  • Calprotectin
  • Alpha-1-antitrypsin
  • TRFLP
  • Q-PCR
Complete list of historical versions of study NCT01007331 on ClinicalTrials.gov Archive Site
  • 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 ]
  • IL-8 from milk samples
  • ECP from milk samples
Not Provided
Not Provided
 
Probiotic Bacteria to Infants With Atopic Dermatitis
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Atopic Dermatitis
Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
10^10 colony forming units pr day of probiotics
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Atopic dermatitis

Exclusion Criteria:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication
Both
6 Months to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01007331
KF-D200 Probørn
No
Kim Fleischer Michaelsen, Department of Human Nutrition, University of Copenhagen
University of Copenhagen
Not Provided
Principal Investigator: Kim F Michaelsen, Professor Department of Human Nutrition, University of Copenhagen
University of Copenhagen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP