Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome - A Monocentric, Prospective, Randomized, Double-blind and Placebo-controlled Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
研究概览
简要总结
Trichuris suis ova (TSO) is a probiotic treatment based on the hygiene hypothesis, that has proven safe and effective in autoimmune inflammatory bowel disease. Clinical trails indicate that helminth infections have an immunomodulatory effect in multiple sclerosis as well. Investigators hypothesize that TSO® 2500 eggs given oral every 2 weeks for 12 months is - due to its immunomodulatory and antiinflammatory effect - in recurrent remittent multiple sclerosis and clinically isolated syndrome significantly more effective than an oral placebo treatment as assed by new T2 lesions in cerebral magnetic resonance imaging and clinical examination.
详细描述
TSO has an impact on the Th1-Th2 balance and effects Il-10 producing B-cells, mechanisms that result in an antiinflammatory effect.
A 12 month treatmet with TSO is safe and well-tolerated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome
- •inefficacy or intolerance for a therapy with Interferon-beta
- •age 18 - 65
排除标准
- •secondary or primary chronic progressive Multiple Sclerosis
- •Immunomodulatoric or immunosuppressive therapy
研究组 & 干预措施
Drug: Trichuris suis ova
Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
干预措施: Trichuris suis ova (Drug)
Placebo
Drug: Placebo, fluid every 2 weeks
干预措施: Trichuris suis ova (Drug)
结局指标
主要结局
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
时间窗: after 12 months of treatment
次要结局
- reduction NAA/Cr-ratio in MR-spectroscopy(after 12 month of treatment)
- Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)(after 12 months of treatment)
- Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)(after 12 months of treatment)
- Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),(after 12 months of treatment)
- Number of Participants with Adverse Events(participants will be followed for the duration of the study and have every 3 month planed visits.)
研究者
Berit Rosche
Dr. med.
Charite University, Berlin, Germany