Probiotic Bacteria to Infants With Atopic Dermatitis

Study Overview
=================
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: 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.

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

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atopic dermatitis Exclusion Criteria: Chronic diseases other than atopic dermatitis Chronic medication

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07|10^10 colony forming units pr day of probiotics|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring atopic dermatitis (SCORAD) index |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin E (IgE) Total |  | 6 months | 
| 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 | 
| Interferon gamma (IFN-gamma) |  | 6 months | 
| Calprotectin |  | one year | 
| Polymerase Chain Reaction (PCR) |  | 8 months | 
| Eosinophil Cation Protein (ECP) |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infants, Atopic Dermatitis, SCORAD, IgE, Eosinophil Cation Protein, Calprotectin, Intestinal microflora