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Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: A randomized, double-blind, placebo-controlled trial

Lookup NU author(s): Dr Suzy Leech

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Abstract

Background: The hygiene hypothesis is often proposed to explain the high prevalence of atopy in the western world. Dysregulation of the immune system may result from inadequate exposure to micro-organisms such as mycobacteria. A small trial suggested that a killed extract of Mycobacterium vaccae ameliorates atopic dermatitis (AD). Objectives: To confirm in a large clinical trial whether killed M. vaccae ameliorates AD in 5-16-year-old children. Methods: This was a randomized, placebo-controlled, double-blind, multi-centre study of the effect of intradermal injection of killed M. vaccae (0.1 or 1 mg) on patients, aged 5-16, with moderate-to-severe AD. Patients were followed up for 24 weeks. The primary end point was the change in severity of AD at 12 weeks, assessed using the six area, six-sign, atopic dermatitis (SASSAD) score. Secondary end points included changes in disease extent, patient's global assessment and children's dermatology life quality index. Results: There were 166 patients randomized. The mean SASSAD score fell to a similar degree at week 12 in all treatment arms: from 33 to 24, (26%) in the high-dose group, from 30 to 23 (25%) in the low-dose group and from 36 to 27 (24%) in the placebo group (P>0.05). Secondary end points followed the same trend. Adverse events were generally those expected to occur in this population. Injection site reactions occurred in 32 patients at week 4. Conclusions: M. vaccae was no more effective than the placebo in ameliorating the severity of AD. © 2006 The Authors.

Publication metadata

Author(s): Berth-Jones J, Arkwright PD, Marasovic D, Savani N, Aldridge CR, Leech SN, Morgan C, Clark SM, Ogilvie S, Chopra S, Harper JI, Smith CH, Rook GAW, Friedmann PS

Publication type: Article

Publication status: Published

Journal: Clinical and Experimental Allergy

Year: 2006

Volume: 36

Issue: 9

Pages: 1115-1121

ISSN (print): 0954-7894

ISSN (electronic): 1365-2222

Publisher: Wiley-Blackwell Publishing Ltd.

URL: http://dx.doi.org/10.1111/j.1365-2222.2006.02558.x

DOI: 10.1111/j.1365-2222.2006.02558.x

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