Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148667
• Other study ID #: 12/2006 1 531
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: June 21, 2010
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2010
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

Inclusion Criteria:

• clinical diagnosis of atopic dermatitis

• age 4 we - 18 mo

Exclusion Criteria:

• skin infection or severe infection at the time of enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Gut Microbiota
• Humoral Immune Responses
• Severity of Atopic Dermatitis
• Skin Microbiota

Intervention

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.
• Infants drink casein hydrolysate without LGG
Infants drink extensively hydrolysed casein formula without added LGG

Locations

Country	Name	City	State
Finland	Turku University Central Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Academy of Finland, Mead Johnson Nutrition

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of atopic dermatitis	Severity of atopic dermatitis of the study infants will be assessed by SCORAD index	March 2007 - July 2008	No
Secondary	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	March 2007 - July 2008	No