Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
NCT ID: NCT01148667
Last Updated: 2010-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2007-03-31
2008-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Infants drink formula added with LGG
Infants have been randomized (1:1) to get casein hydrolysate with or without LGG
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.
Infants drink casein hydrolysate without LGG
Infants get extensively hydrolysed casein formula
Infants drink casein hydrolysate without LGG
Infants drink extensively hydrolysed casein formula without added LGG
Interventions
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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.
Infants drink casein hydrolysate without LGG
Infants drink extensively hydrolysed casein formula without added LGG
Eligibility Criteria
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Inclusion Criteria
* age 4 we - 18 mo
Exclusion Criteria
4 Weeks
18 Months
ALL
No
Sponsors
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Academy of Finland
OTHER
Mead Johnson Nutrition
INDUSTRY
Turku University Hospital
OTHER_GOV
Responsible Party
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University of Turku
Locations
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Turku University Central Hospital
Turku, , Finland
Countries
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References
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Nermes M, Kantele JM, Atosuo TJ, Salminen S, Isolauri E. Interaction of orally administered Lactobacillus rhamnosus GG with skin and gut microbiota and humoral immunity in infants with atopic dermatitis. Clin Exp Allergy. 2011 Mar;41(3):370-7. doi: 10.1111/j.1365-2222.2010.03657.x. Epub 2010 Dec 1.
Other Identifiers
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12/2006 1 531
Identifier Type: -
Identifier Source: org_study_id
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