Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Humoral Immune Responses; Gut Microbiota; Skin Microbiota; Severity of Atopic Dermatitis

Treatments: Dietary Supplement: Casein hydrolysate added with LGG; Dietary Supplement: Infants drink casein hydrolysate without LGG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01148667

12/2006 1 531

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 4 weeks to 18 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Infants drink formula added with LGG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Casein hydrolysate added with LGG

Infants drink casein hydrolysate without LGG

Placebo Comparator group

Description:

Infants get extensively hydrolysed casein formula

Treatment:

Dietary Supplement: Infants drink casein hydrolysate without LGG