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临床试验/NCT06647277
NCT06647277尚未招募1 期

An Open-Label Phase I Clinical Trial of Vancomycin Followed by Fecal Microbiota Transplant for the Treatment of Parkinson's Disease

ProgenaBiome1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Parkinson's disease symptoms

研究概览

简要总结

FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.

详细描述

This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease. Subjects in the study are required to meet with the study clinician on 11 occasions: two (2) visits for informed consent and baseline assessment, one (1) visit prior to FMT for colonoscopy instructions and exam, one (1) visit for the fecal microbiota transplant procedure by colonoscopy at an outpatient surgical center, seven (7) visits for post-FMT assessment. There are also daily phone calls in the week following the FMT, and weekly phone call visits (during weeks in which there is not a physical visit) to check up on how the subject is doing, any change in medications, side effects, and answer any questions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals diagnosed with PD

排除标准

  • •Non-PD individuals

研究组 & 干预措施

PD patients

Other

This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease.

干预措施: Fecal Microbiota Transplant (Combination Product)

结局指标

主要结局

Parkinson's disease symptoms

时间窗: 6.5 months for each subject

Changes in symptoms reported

次要结局

  • Alterations in Subject microbiome from baseline(6.5 months for each subject)

研究者

发起方
ProgenaBiome
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabine Hazan

Principal Investigator

ProgenaBiome

研究点 (1)

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