Fecal Microbiota Transplantation for the Treatment of Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Primary endpoint
研究概览
简要总结
Fecal microbiota transplantation (FMT) is an effective and safe treatment for Clostridioides difficile infection (CDI). Though CDI is the only indication for FMT, more and more preliminary data on FMT in neurological disorders are reported due to gut-brain axis. This study is a pilot study to apply FMT on patients with Parkinson's disease (PD). The effect of FMT on motor and non-motor symptoms in PD will be also evaluated.
详细描述
- Screening and Enrollment Participants will be recruited from movement disorders clinics at Chang Gung Memorial Hospital (CGMH). Written informed consent will be obtained prior to study participation. Control group participants will undergo the same evaluation protocol as the treatment group, except for fecal microbiota transplantation (FMT).
- Clinical Assessments Before the baseline visit, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed.
Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT.
Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months. 3. Donor Screening and Specimen Processing Healthy donors will undergo comprehensive screening, including medical history, risk assessment, and laboratory testing, in accordance with national FMT consensus guidelines. Eligible donors will provide stool samples under standardized conditions.
Samples will be processed at the CGMH microbiota center following established protocols, including preparation for microbiome and metabolite analyses (e.g., short-chain fatty acids) using validated laboratory methods such as gas chromatography-mass spectrometry (GC-MS). Blood samples from participants will also be collected and stored for analysis. 4. Clinical Outcome Measures
Assessments will include:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of idiopathic PD according to UK brain bank criteria.
- •PD disease duration ≧5 years to avoid the possible misdiagnosis of atypical parkinsonism.
- •Hoehn-Yahr stage 1-4
- •Using levodopa in a currently fixed dose.
- •Presence of motor complications (motor fluctuation or dyskinesia).
- •Written informed consent.
- •Age above 18.
排除标准
- •Hoehn-Yahr stage
- •(wheelchair ridden or bedridden due to PD)
- •Dementia (MMSE<24), history of encephalitis, or brain organic lesions, including congenital or acquired structural abnormalities (which were detected through brain computed tomography scan or Magnetic Resonance Imaging) may affect neurological function, leading to various neurological deficits and mpairing the cognitive function.
- •Current use of probiotics or in the past 3 months.
- •For women with childbearing potential. (Female participants are suggested to prevent pregnancy during this trial and undergo a pregnancy test before enrollment.)
- •Current need of antibiotics or use in the previous 3 months.
- •End stage renal disease caused uremic encephalopathy or liver cirrhosis caused hepatic encephalopathy
- •Immunocompromised state.
研究组 & 干预措施
Experimental Group
In the experimental group, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed.
Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT.
Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months.
干预措施: Fecal microbiota transplantation (Procedure)
Control Group
In the control group, all the assessments will be conducted at the baseline, 3 months, and 6 months. Stool samples will be collected at baseline, 3 months, and 6 months.
干预措施: Not received Fecal microbiota transplantation (Procedure)
结局指标
主要结局
Primary endpoint
时间窗: 6 months
The improvement of the motor section scores of MDS-UPDRS in an off- medication state, from baseline to 6 months post-FMT for the treatment group compared to the control group.
次要结局
- Secondary endpoints(6 months)