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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:
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:
Fecal samples will be collected to examine:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 | Behavioral | 10^10 colony forming units pr day of probiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Scoring atopic dermatitis (SCORAD) index | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin E (IgE) Total | 6 months | |
| Immunoglobulin E (IgE) specific for Egg | 6 months | |
| Immunoglobulin E (IgE) specific for Milk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim F Michaelsen, Professor | Department of Human Nutrition, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Nutrition | Rolighedsvej 30 | Frederiksberg C | 1958 | Denmark |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| 6 months |
| Interleukin-10 (Il-10) | 6 months |
| Interleukin-12 (Il-12) | 6 months |
| Interferon gamma (IFN-gamma) | 6 months |
| Calprotectin | one year |
| Polymerase Chain Reaction (PCR) | 8 months |
| Eosinophil Cation Protein (ECP) | 7 months |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |