NCT03671785已完成1 期
A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
研究概览
简要总结
The purpose of this study is to characterize the intestinal microbiome in subjects with Parkinson's disease and to determine safety and trends in improvements in diversity of colonic microbiome following administration of lyophilized PRIM-DJ2727
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Parkinson's Disease (PD) for less than or equal to 10 years based on the United Kingdom Brain Bank Criteria and the Modified Hoehn-Yahr (H&Y) staging system of less than 3 in the "OFF medicine" state of at least 8-12 hours (subjects should have an asymmetric and unilateral symptoms onset).
- •Mild microsomia to anosmia (The University of Pennsylvania Smell Identification Test (UPSIT) less than 33), which is supportive of idiopathic PD.
- •Robust response to dopaminergic therapy (defined as greater than 33% reduction in symptoms (on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III)) when measured in the ON medicine state compared to OFF state.
- •Subject has a history of constipation.
- •Sexually active male and female subjects of child-bearing potential agree to use an effective method of birth control during the study.
- •Female subjects of child-bearing potential must have a negative urine Qualitative Human chorionic gonadotropin (hCG) pregnancy test at enrollment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
- •Willing and able to sign an informed consent form and attend study assessments and follow ups.
- •Subject has an attending physician who will provide non-transplant care for the subject.
- •Subject is able to maintain a stable Parkinson's therapy medical regimen during participation in the study.
排除标准
- •Unable to take multiple capsules orally.
- •Montreal Cognitive Assessment (MoCA) Score less than or equal to
- •Atypical, vascular or drug-induced Parkinsonism.
- •Clinical features of psychosis or refractory hallucinations.
- •Unstable Parkinson's disease symptomatic therapy (defined as recent changes or additions to the PD regimen).
- •Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking systemic steroids greater than 20 milligrams (mg) a day or prednisone-equivalent)
- •Receipt of systemic non-topical antibiotic therapy currently or within 14 days of enrollment.
- •Prior Deep Brain Stimulation, or surgical intervention for PD, intravenous glutathione therapy or stem cell therapy.
- •History of medium or large vessel cerebrovascular accidents.
- •History of use of an investigational drug within 90 days prior to the screening visit.
- •Positive results for human immunodeficiency virus (HIV) or Hepatitis B / C.
- •Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
- •History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
- •Life expectancy of less than 1 year.
- •In the opinion of investigator, subject for any reason, should be excluded from the study
研究组 & 干预措施
Active group treated with healthy fecal microbiota
Experimental
干预措施: PRIM-DJ2727 (Drug)
Placebo group
Experimental
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
时间窗: month 9
Any untoward medical occurrence after fecal microbiota transplantation (FMT)
时间窗: 9 months after treatments starts
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
时间窗: month 9
The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.
次要结局
- Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score(9 months)
- Quality of Life as assessed by the Parkinson Disease Non-Motor Symptoms (PD NMS) Questionnaire(9 months)
- Change in number of bowel movements per day(Baseline, 2 weeks)
- Motor function as characterized by Unified Parkinson's Disease Rating Scale (UPDRS) Total Score(9 months)
- Change in Sense of Smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT)(baseline, 9 months)
- Number of participants with an increase in flora diversity in fecal samples(9 months after treatments starts)
- Cognitive domains characterized by using Montreal Cognitive Assessment(9 months)
- Qualify of life as assessed by the Parkinson's disease Questionnaire (PDQ-39)(9 months)
- Anxiety as assessed by the Parkinson Anxiety Scale (PAS)(9 months)
- Parkinson's disease symptoms as assessed by the Modified Hoehn and Yahr Scale(9 months)
- Number of participants who changed required PD symptomatic therapy after treatment(9 months after treatment)
- Number of participants with worsening of PD symptoms or other potential microbial-mediated disorders(9 months after treatment)
- Depression as assessed by the Geriatric Depression Scale Short form (GDS-SF)(9 months)
- Change in gastric emptying time (GET) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule(baseline, 13 weeks)
- Change in small bowel transit time (SBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule(baseline, 13 weeks)
- Change in colon transit time (CTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule(baseline, 13 weeks)
- Change in small/large bowel transit time (SLBTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule(baseline, 13 weeks)
- Change in whole gut transit time (WGTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule(baseline, 13 weeks)
研究者
Herbert DuPont, MD
Professor of Infectious Diseases
The University of Texas Health Science Center, Houston
研究点 (1)
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