Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial

Trials

Friedemann Paul²  Jan-Markus Dörr³  Stephanie Ohlraun³  Klaus-Dieter Wernecke¹  Berit Rosche⁴ 

[1] SOSTANA GmbH and Charité, Universitätsmedizin Berlin, Berlin, Germany;Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitätsmedizin Berlin, Berlin, Germany;NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, Berlin, Germany;Clinical and Experimental Multiple Sclerosis Research Center, Charité - Universitätsmedizin Berlin, Berlin, Germany

关键词: Hygiene hypothesis;    Immmunomodulation;    Intervention;    Clinical trial;    Trichuris suis ova;    Multiple sclerosis;   

Others  :  1094214
DOI  :  10.1186/1745-6215-14-112

 received in 2012-09-12, accepted in 2013-04-08,  发布年份 2013

【 摘 要 】

Background

Trichuris suis ova is a probiotic treatment based on the hygiene hypothesis. It has been demonstrated as safe and effective in autoimmune inflammatory bowel diseases and clinical trials indicate that helminth infections also have an immunomodulatory effect in multiple sclerosis.

We hypothesize that administering 2,500 Trichuris suis ova eggs orally every two weeks for 12 months is - due to its immunomodulatory and anti-inflammatory effect - significantly more effective than oral placebo in preventing new T2 and Gd+ lesions, as quantified by cerebral MRI and clinical examination, in relapsing-remitting multiple sclerosis and clinically isolated syndrome.

Methods/Design

Fifty patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome with clinical activity, not undergoing any standard therapies, will be randomized 1:1 to Trichuris suis ova 2,500 eggs every two weeks or matching placebo. The safety, tolerability and effect on disease activity and in vivo mechanisms of action of Trichuris suis ova in MS will be assessed by neurological, laboratory and immunological exams and magnetic resonance imaging throughout the 12-month treatment period and over a follow-up period of 6 months. Various immunological analyses will be used to assess the overall patient immune response prior to and at varying time points following treatment with Trichuris suis ova.

Discussion

We anticipate that Trichuris suis ova will be well tolerated and more effective than the placebo in preventing new T2 and Gd+ lesions, as quantified by MRI. We also expect the Th1/Th17 proinflammatory response to shift towards the more anti-inflammatory Th2 response. This study has important clinical implications and will involve extensive research on the immunology of helminth therapy.

Trial registration

ClinicalTrials.gov: NCT01413243

【 授权许可】

   
2013 Rosche et al.; licensee BioMed Central Ltd.

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