Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled trial
Randomized controlled trial published in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology (2006)
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Резюме
The hygiene hypothesis is often proposed to explain the high prevalence of atopy in the western world.
Почему это важно для гирудотерапии
This randomized, double-blind, placebo-controlled, multicenter trial evaluated whether killed Mycobacterium vaccae suspension intradermally injected could ameliorate moderate-to-severe atopic dermatitis in children aged 5–16, with SASSAD severity score change at 12 weeks as the primary endpoint. All treatment arms showed similar improvement (~24–26% reduction), with no statistically significant difference between M. vaccae (high or low dose) and placebo. This article has no connection to leeches, hirudotherapy, hirudin, or the leech secretome. There is no defensible relevance to ASH's domain; the study is an immunotherapy trial for childhood atopic dermatitis with no anticoagulant or leech-related content whatsoever.
Цитирование
Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled trial
Berth-Jones J et al. · Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2006
Связанный клинический контекст
Узнайте, как это исследование связано с клинической практикой
Добавлено в библиотеку ASH: May 27, 2026 · Последнее обновление сайта: June 18, 2026