Effect of a Mycobacterium vaccae derivative on paediatric atopic dermatitis: a randomized, controlled trial.
BACKGROUND
The prevalence of atopic diseases in the Western world is rising while infectious diseases decline. The 'hygiene hypothesis' suggests that reduced exposure to microbes such as mycobacteria in early life is associated with increased atopic disease. Recent research showed that Mycobacterium vaccae reduced the severity of atopic dermatitis (AD) in children.


OBJECTIVE
To evaluate the efficacy of a derivative of heat-killed M. vaccae in children with AD.


METHODS
In total, 129 children, aged 5-16 years old with moderate to severe AD participated in this randomized, double-blind, placebo-controlled trial. Participants received an intradermal injection of either M. vaccae or placebo three times at 2-weekly intervals. The two groups were compared for changes in severity and extent of AD from baseline to 3 and 6 months after treatment.


RESULTS
There was no significant difference between the two groups for change in severity of AD at 3 and 6 months (P = 0.77 and P = 0.70, respectively) or in extent of disease at 3 months (P = 1.0). Local injection-site reactions occurred in 47% of participants, of whom 75% received M. vaccae.


CONCLUSIONS
In this study, M. vaccae did not improve AD significantly in children with moderate to severe disease.
Brothers
S
S
Department of Paediatrics, Child and Youth Health, Faculty of Medical and Health Sciences, The University of Auckland, Auckland 1142, New Zealand.
Asher
M I
MI
Jaksic
M
M
Stewart
A W
AW
D000293:Adolescent; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000276:immunology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D009161:Mycobacterium / Q000276:immunology*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000627:therapeutic use
D001428:Bacterial Vaccines; D015164:Vaccines, Inactivated; D007073:Immunoglobulin E