Probiotic Bacteria to Infants With Atopic Dermatitis
|Atopic Dermatitis||Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- Scoring atopic dermatitis (SCORAD) index [ Time Frame: 5 months ]
- 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 ]
|Study Start Date:||November 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007331
|Institute of Human Nutrition|
|Rolighedsvej 30, Frederiksberg C, Denmark, 1958|
|Principal Investigator:||Kim F Michaelsen, Professor||Department of Human Nutrition, University of Copenhagen|