NCT01148667

Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 4 Weeks – 18 Months
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Infants drink casein hydrolysate without LGG	Infants drink extensively hydrolysed casein formula without added LGG

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2010-06-22
• Last updated: 2010-06-22

Locations

1 site across 1 country: Finland