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Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
Mead Johnson Nutrition
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01148667
First received: June 21, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • severity of atopic dermatitis [ Time Frame: March 2007 - July 2008 ] [ Designated as safety issue: No ]
    Severity of atopic dermatitis of the study infants will be assessed by SCORAD index


Secondary Outcome Measures:
  • Maturation of humoral immune responses [ Time Frame: March 2007 - July 2008 ] [ Designated as safety issue: No ]
    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


Enrollment: 40
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • skin infection or severe infection at the time of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148667

Locations
Finland
Turku University Central Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Academy of Finland
Mead Johnson Nutrition
  More Information

No publications provided by Turku University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Erika Isolauri, University of Turku
ClinicalTrials.gov Identifier: NCT01148667     History of Changes
Other Study ID Numbers: 12/2006 1 531
Study First Received: June 21, 2010
Last Updated: June 21, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
atopic dermatitis
barrier function
gut
probiotics
skin

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013