Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Clinical evidence for active disease
研究概览
简要总结
The goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.
详细描述
Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls.
More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of MS (as defined by the 2010 McDonald criteria).
- •Occurrence of symptoms no longer than 5 years before baseline.
- •Willingness to participate in the study and to sign the informed consent.
排除标准
- •Treatment with high doses of systemic steroids 2 months before baseline.
- •Use of antibiotics 3 months before baseline.
- •Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).
- •Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis).
- •Additional inclusion criteria for MS patients undergoing a relapse:
- •Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for >=24 hours in the absence of fever.
- •Additional exclusion criteria for MS patients undergoing a relapse:
- •Treatment with cortisone before collection of baseline faecal sample.
- •Evidence of a relapse less than 2 months before baseline.
- •Switching disease modifying treatment less than 2 months before baseline.
- •Inclusion criteria healthy controls:
- •Willingness to participate to the study and to sign the informed consent.
- •Exclusion criteria healthy controls:
- •Neurodegenerative disorders.
- •Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis).
- •Use of antibiotics 3 months before baseline.
- •Treatment with high doses of systemic steroids 2 months before baseline.
研究组 & 干预措施
Multiple sclerosis (MS) patients
Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
干预措施: Magnetic resonance imaging (MRI) (Other)
Healthy controls
Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
Multiple sclerosis (MS) patients undergoing a relapse
Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
Multiple sclerosis (MS) patients from multiplex MS families
Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.
结局指标
主要结局
Clinical evidence for active disease
时间窗: 3 years
Time to first relapse (after baseline) will be reported for all patients.
次要结局
- Radiological evidence for active disease(3 years)
研究者
Marie D'hooghe
Prof. Dr.
National MS Center Melsbroek