Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Study Overview
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Brief Summary
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Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms. Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu. Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).

Official Title
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Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis

Conditions
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Gut Microbiota, Skin Microbiota, Humoral Immune Responses, Severity of Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: Casein hydrolysate added with LGG
* Dietary Supplement: Infants drink casein hydrolysate without LGG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of atopic dermatitis age 4 we - 18 mo Exclusion Criteria: skin infection or severe infection at the time of enrollment

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infants drink formula added with LGG<br>Infants have been randomized (1:1) to get casein hydrolysate with or without LGG | Dietary Supplement: Casein hydrolysate added with LGG<br>* Infants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu.<br>|
| Placebo Comparator: Infants drink casein hydrolysate without LGG<br>Infants get extensively hydrolysed casein formula | Dietary Supplement: Infants drink casein hydrolysate without LGG<br>* Infants drink extensively hydrolysed casein formula without added LGG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of atopic dermatitis | Severity of atopic dermatitis of the study infants will be assessed by SCORAD index | March 2007 - July 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation of humoral immune responses | Determination of proportions of immunoglobulin secreting cells among peripheral blood mononuclear cells was carried out by ELISPOT assay. The proportions of CD 19+ memory B cells was carried out by flow cytometry | March 2007 - July 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, barrier function, gut, probiotics, skin