Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis

Study Overview
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Brief Summary
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To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.

Detailed Description
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To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants

Official Title
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Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.

Conditions
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Atopic Dermatitis, Atopic Eczema, Infantile Eczema

Intervention / Treatment
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* Drug: probiotics: Lactobacillus GG, lactobacillus Rhamnosus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis Suggestive of CMA (one additional symptom) Scorad index (total) >20 at study entry Below 5 months of age Formula, not breast fed Written informed consent from the parents Exclusion Criteria: • Previous or current use of anti-histamines, oral corticosteroids, probiotics Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia) Other GI disease with intestinal inflammation and/or increased intestinal permeability Skin disorder, not atopic dermatitis Participation in another clinical study

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: probiotics: Lactobacillus GG, lactobacillus Rhamnosus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant decrease of SCORAD score in treated infants compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells |  |  | 
| change in fecal TNF-α and α-1-antitrypsin, urinary EDN |  |  | 
| effect on faecal bacteria after probiotics |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, SCORAD, probiotics, cytokines, Infant