A Randomized, Double Blind, Placebo Controlled Multicenter Trial of Fecal Microbiome Transplantation Safety and Efficacy for Parkinson's Disease Patients with Abnormal Gut Microbiota Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Change of the sum of MDS-UPDRS I-III from baseline
研究概览
简要总结
48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.
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)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD (Clinically Probable PD)
- •H&Y OFF 1-3 at Baseline Visit
排除标准
- •Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
- •Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
- •Any abdominal surgery in the last 3 months
- •Major genital and/or rectum prolapse
- •Active autoimmune disease
- •Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
- •Immune deficiency
- •HIV infection
- •Antibiotic use in last 3 months before baseline visit
- •Dementia as indicated by Moca <21p
- •Active significant impulse control disorder (by interview and medical records)
- •Major depression as indicated by BDI-II >28
- •Alcohol or drug abuse
- •Negative dysbiosis test result
- •Iodine allergy
- •Deep brain stimulation or Duodopa/Lecigon treatment
- •Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments
结局指标
主要结局
Change of the sum of MDS-UPDRS I-III from baseline
时间窗: at 6 months post intervention
Sum of Movement Disorder Society Unified Parkinson's Disease Rating Scale sum of parts I, II, and III (in OFF state); Min 0 - Max 236 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be the primary outcome measure; Min 0 - Max 236 points (higher points indicating stronger improvement)
次要结局
- Change of MDS-UPDRS III from baseline(at 6 and 12 months post intervention)
- Change of MDS-UPDRS IV from baseline(at 6 and 12 months post intervention)
- Change of Timed UP GO test from baseline(at 6 and 12 months post intervention)
- Change of MDS-UPDRS I from baseline(at 6 and 12 months post intervention)
- Change of NMSS from baseline(at 6 and 12 months post intervention)
- Change in gut permeability, motility and volume from baseline(at 6 months)
- Change of fecal and blood markers from baseline(whole study period)
- Change of BDI-II from baseline(at 6 and 12 months post intervention)
- Change of BAI from baseline(at 6 and 12 months post intervention)
- Change of RBDSQ from baseline(at 6 and 12 months after intervention)
- Change of MoCa from baseline(at 6 and 12 months post intervention)
- Change of IBS-SSS from baseline(at 6 and 12 months after intervention)
- Change of PDQ39 index from baseline(at 6 and 12 months post intervention)
研究者
Filip Scheperjans
Adjunct Professor of Neurology
Helsinki University Central Hospital