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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).


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01148667
Study type Interventional
Source Turku University Hospital
Contact
Status Completed
Phase Phase 4
Start date March 2007
Completion date July 2008

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