Atopic Dermatitis
Conditions
Keywords
Infants, Atopic Dermatitis, SCORAD, IgE, Eosinophil Cation Protein, Calprotectin, Intestinal microflora
Brief summary
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.
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.
Interventions
BEHAVIORALLactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
10\^10 colony forming units pr day of probiotics
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Atopic dermatitis
Exclusion criteria
* Chronic diseases other than atopic dermatitis * Chronic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scoring atopic dermatitis (SCORAD) index | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Immunoglobulin E (IgE) specific for Egg | 6 months |
| Immunoglobulin E (IgE) specific for Milk | 6 months |
| Interleukin-10 (Il-10) | 6 months |
| Interleukin-12 (Il-12) | 6 months |
| Immunoglobulin E (IgE) Total | 6 months |
| Calprotectin | one year |
| Polymerase Chain Reaction (PCR) | 8 months |
| Eosinophil Cation Protein (ECP) | 7 months |
| Interferon gamma (IFN-gamma) | 6 months |
Countries
Denmark
Outcome results
None listed