Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Changes in T2 Lesions - MRI
研究概览
简要总结
This is a placebo-controlled, double-blinded, randomized trial design, whereby all patients are eligible to start an injectable therapy, and then randomized to either placebo or FMT for approximately 1 year.
详细描述
Fecal Microbiome Transplants: Patients will undergo pretreatment with Amoxicillin/Clavulinate (or matched placebo) for 5 days followed by a bowel cleanse with PEGLYTE. Patients will undergo allogeneic or autologous fecal transplants. Patients will be dosed with FMT oral capsules approximately 48 hours after antibiotic treatment has stopped. Following the FMT capsule treatment on day 1, patients will be administered a repeat oral capsule or placebo dose at 3 weeks. Oral omeprazole or omeprazole placebo will be given 1 hour prior to the baseline and 3 week dose. This will be done to ensure full engraftment of the transplant.
Participants will be seen at baseline, 3 weeks, 6 weeks, 3 months, 6 months and 12 months. A series of neurological tests will be performed for safety measures. In addition to this, MRIs will be completed at baseline, 6 weeks and 12 months. Blood, urine and stool samples will also be collected for data analysis and safety measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 55 years of age
- •Have an expanded disability status scale (EDSS) of < 6
- •Have a diagnosis of relapsing multiple sclerosis
- •Have evidence of radiographic activity within the 12 months on MRI (new/enlarging T2 lesion or gadolinium enhancing lesion)
- •Eligible to start/starting an injectable DMT
- •Not on a DMT currently and/or not on a DMT in last 6 months
- •Ability to swallow capsules
排除标准
- •Unable to provide informed consent
- •Does not pass the standard MRI screening questionnaire
- •Other disease that can affect GI permeability (such as Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, indeterminate colitis or microscopic colitis, celiac disease)
- •Expected requirement for antibiotics within 3 months (chronic suppressive therapies, elective prosthetic joint insertion)
- •Toxic megacolon, small bowel ileus
- •Penicillin allergy
- •Omeprazole allergy
结局指标
主要结局
Changes in T2 Lesions - MRI
时间窗: Baseline, 6 weeks, 12 months
Assess the number of new/enlarging/gad enhancing T2 lesions. We will be comparing baseline to 6 weeks and 6 weeks to 12 months.
次要结局
- Stool Microbiome(Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months)
- Neurofilament Light Serum Levels(Baseline, 6 weeks, 3 months, 12 months)
- Intestinal Permeability(Baseline, 6 weeks, 12 months)
- Blood Brain Barrier - MRI(Baseline, 6 weeks, 12 months)
- IgA Microbiota(Baseline, 3 weeks, 6 weeks, and 12 months)
- Metabolomics(Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months)
研究者
Michael Silverman, MD
Chair/Chief of Infectious Diseases
Lawson Health Research Institute