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Completed

NCT Number: NCT01148667

Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

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).

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Key information

Conditions

Gut Microbiota Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Humoral Immune Responses Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Severity of Atopic Dermatitis Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Microbiota Skin and Connective Tissue Diseases

Age range

4 week–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Turku University Central Hospital

Turku, 20520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of atopic dermatitis
  • age 4 we - 18 mo

Exclusion criteria

  • skin infection or severe infection at the time of enrollment

Treatment and study plan

Casein hydrolysate added with LGG

Dietary Supplement

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

Dietary Supplement

Infants drink extensively hydrolysed casein formula without added LGG

Primary outcomes

  1. severity of atopic dermatitis

    Time frame: March 2007 - July 2008

    Severity of atopic dermatitis of the study infants will be assessed by SCORAD index

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Academy of Finland
  • Mead Johnson Nutrition

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 22, 2010
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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