Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA/Tonalin® FFA 80) and Probiotics (Vivomixx®/VSL#3) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with Tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (DMT, interferon-beta derivatives as well as glatirameracetate and other glatirameroids) in relapsing remitting MS (RRMS).
100 patients will be randomly assigned in a 1:1 ratio to receive either both food supplements for 48 weeks or to receive placebo in addition to their established first-line disease modifying treatment (DMT). The two randomized groups will be compared concerning the change in volume of T2-weighted hyperintense lesions from baseline to 48 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomized after successful screening and inclusion. They will be randomized with a 1:1 ratio to receive either conjugated linoleic acid (CLA/Tonalin®) and probiotics (Vivomixx®) or the corresponding placebos as add-on therapy. Randomization will be stratified according to first-line therapy with Interferon-beta, Glatirameracetat / other glatirameroids, or Teriflunomid.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing-remitting multiple sclerosis according to current McDonald Criteria, EDSS maximal 5.5, 18-60 years
- •stable treatment with first-line DMT (IFNbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months
- •absence of a clinical relapse for at least 3 months before inclusion
- •Written informed consent
排除标准
- •diagnosis of primary or secondary progressive MS or other active autoimmune disease
- •intake/administration of the following disease modifying therapies:
- •at any time point: alemtuzumab, cladribine
- •during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod
- •during the last 12 months before inclusion: mitoxantron, ocrelizumab, ofatumumab, rituximab
- •ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium, prebiotics, such as omega-3-fatty acids)
- •significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions)
- •accompanying systemic immunosuppressive treatment
- •relevant dietary restriction (e.g. strictly vegan nutrition)
- •women during pregnancy or lactation
结局指标
主要结局
Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy
时间窗: 48 weeks
The two randomised study groups (intervention and placebo groups) are compared with regard to the change of volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' (hereafter T2 lesions) between the start of the study and after 48 weeks. T2 lesions were chosen as primary endpoint as this has been used as a surrogate marker of efficacy in several recent MS studies
次要结局
- Change in T2 lesions at 48 weeks compared to baseline(48 weeks)
- Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images(48 weeks)
- Annualized relapse rate(48 weeks)
- Number of new or enlarging T2-weighted hyperintense lesions(48 weeks)