Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
|ClinicalTrials.gov Identifier: NCT01148667|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : June 22, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Gut Microbiota Skin Microbiota Humoral Immune Responses Severity of Atopic Dermatitis||Dietary Supplement: Casein hydrolysate added with LGG Dietary Supplement: Infants drink casein hydrolysate without LGG||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis|
|Study Start Date :||March 2007|
|Primary Completion Date :||July 2008|
|Study Completion Date :||July 2008|
Active Comparator: Infants drink formula added with LGG
Infants have been randomized (1:1) to get casein hydrolysate with or without LGG
Dietary Supplement: Casein hydrolysate added with LGG
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.
Placebo Comparator: Infants drink casein hydrolysate without LGG
Infants get extensively hydrolysed casein formula
Dietary Supplement: Infants drink casein hydrolysate without LGG
Infants drink extensively hydrolysed casein formula without added LGG
- severity of atopic dermatitis [ Time Frame: March 2007 - July 2008 ]Severity of atopic dermatitis of the study infants will be assessed by SCORAD index
- Maturation of humoral immune responses [ Time Frame: March 2007 - July 2008 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148667
|Turku University Central Hospital|
|Turku, Finland, 20520|