NCT03026231撤回1 期
A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
研究概览
简要总结
The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis PD with a Hoehn and Yahr stage of < 3 in the "Off medicine" state
- •Sexually active male and female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- •Female subjects of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
- •Subject willing to sign an informed consent form
- •Subject deemed likely to survive for ≥ 1 year after enrolment
- •Subject's attending physician will refer and provide non-transplant care for the subject
- •Subjects must demonstrate adherence to and the ability to maintain a Parkinson's therapy medical regimen that is stable for 90 days before enrolment and participation in the study.
排除标准
- •Greater than 20 grams of ethanol intake daily
- •Unstable Parkinson's disease
- •Other immune disorder or clinical immunosuppression
- •Probiotic used during study period
- •Severe underlying disease such that the subject is not expected to survive for one or more years or unstable medical condition requiring frequent change in treatments
- •Current or recent within one month receipt of an antibiotic with expected activity against enteric bacteria
- •Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous glutathione therapy or stem cell therapy
- •HIV or Hepatitis B / C positive
研究组 & 干预措施
PRIM-DJ2727
Active Comparator
Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules
干预措施: PRIM-DJ2727 (Biological)
Placebo
Placebo Comparator
Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
干预措施: Placebo (for PRIM-DJ2727) (Drug)
结局指标
主要结局
Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
时间窗: 12 months
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
时间窗: 12 months
Most abundant Phylum in Fecal Sample
时间窗: 12 months
次要结局
- Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls(3 years)
- Number of bowel movements per day(12 months)
- Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(12 months)
- Number of participants with a change in required anti-PD symptomatic or levodopa therapy(12 months)
- Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)(12 months)
- Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)(12 months)
- Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares(12 months)
研究者
Herbert DuPont
Professor of Medicine
The University of Texas Health Science Center, Houston
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