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Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Primary Purpose

Gut Microbiota, Skin Microbiota, Humoral Immune Responses

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Casein hydrolysate added with LGG
Infants drink casein hydrolysate without LGG
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gut Microbiota focused on measuring atopic dermatitis, barrier function, gut, probiotics, skin

Eligibility Criteria

4 Weeks - 18 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • skin infection or severe infection at the time of enrollment

Sites / Locations

  • Turku University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Infants drink formula added with LGG

Infants drink casein hydrolysate without LGG

Arm Description

Infants have been randomized (1:1) to get casein hydrolysate with or without LGG

Infants get extensively hydrolysed casein formula

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2010
Last Updated
June 21, 2010
Sponsor
Turku University Hospital
Collaborators
Academy of Finland, Mead Johnson Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01148667
Brief Title
Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
Official Title
Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Turku University Hospital
Collaborators
Academy of Finland, Mead Johnson Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota, Skin Microbiota, Humoral Immune Responses, Severity of Atopic Dermatitis
Keywords
atopic dermatitis, barrier function, gut, probiotics, skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infants drink formula added with LGG
Arm Type
Active Comparator
Arm Description
Infants have been randomized (1:1) to get casein hydrolysate with or without LGG
Arm Title
Infants drink casein hydrolysate without LGG
Arm Type
Placebo Comparator
Arm Description
Infants get extensively hydrolysed casein formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein hydrolysate added with LGG
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Infants drink casein hydrolysate without LGG
Intervention Description
Infants drink extensively hydrolysed casein formula without added LGG
Primary Outcome Measure Information:
Title
severity of atopic dermatitis
Description
Severity of atopic dermatitis of the study infants will be assessed by SCORAD index
Time Frame
March 2007 - July 2008
Secondary Outcome Measure Information:
Title
Maturation of humoral immune responses
Description
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
Time Frame
March 2007 - July 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21121981
Citation
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.
Results Reference
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Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

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