Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Response rate of constipation in Parkinson's Disease (PD)
研究概览
简要总结
Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. At each follow-up visits, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.
详细描述
This prospective, double-blind, randomised, placebo-controlled study aims to evaluate efficacy and safety of fecal microbiota transplantation for constipation in Parkinson's disease. Participants will be given either FMT capsules or placebo capsules at a ratio of 1:1. For experimental group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. After 24-week treatment, participants complete specific scales to assess improvement in constipation, other PD symptoms, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who fulfill Chinese diagnostic criteria for PD (2016 edition), aged 40-75 years;
- •PD Hoehn-Yahr stage 1-3
- •Participants who have at least 2 of the following symptoms in the past 3 months and the symptoms have been present for at least 6 months: ① More than 25% of defecations are laborious; ② More than 25% of defecations consist of hard or lumpy stools; ③ More than 25% of defecations are accompanied by a sensation of incomplete evacuation; ④ More than 25% of defecations are accompanied by a sensation of anorectal obstruction; ⑤ More than 25% of defecations require manual assistance; ⑥ Less than 3 spontaneous bowel movements per week.
- •Have taken a stable dose of anti-Parkinson drugs, antidepressants and antipsychotics for at least 1 month;
- •Absence of red flags such as weight loss, hematochezia and exclusion of other diagnosis;
- •Have signed the informed consent and agree to participate in this study;
排除标准
- •Parkinsonism-plus syndrome;
- •Stroke, brain trauma or epilepsy;
- •Have undergone surgery intervention due to PD;
- •Pregnant, planning pregnancy or lactating;
- •Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- •Immunodeficiency or treatment with immune-modulating medication;
- •Have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- •Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
- •Use of probiotics or antibiotics within 1 month prior to study entry;
- •Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
研究组 & 干预措施
FMT capsule group
Participants will be given 6 FMT capsules twice a week for 24 weeks. The FMT capsules derived from healthy donors.
干预措施: Healthy donor-derived FMT capsule (Drug)
Placebo capsule group
Participants will be given 6 placebo capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell as FMT capsules but contain milk powder.
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Response rate of constipation in Parkinson's Disease (PD)
时间窗: at week 24
Efficacy index is calculated based on Wexner score. Efficacy index ≥30% is defined as response.
次要结局
- Change from baseline fecal metabolites based on non-targeted metabolomics at week 5, week 13 and week 24(at baseline, week 5, week 13 and week 24)
- Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24(at baseline, week 13 and week 24)
- Change from baseline fecal microbiota based on metagenomics sequencing at week 5, week 13 and week 24(at baseline, week 5, week 13 and week 24)
- Change from baseline depression at week 5, week 13 and week 24(at baseline and week 5, week 13 and week 24)
- Change from baseline quality of life at week 5, week 13 and week 24(at baseline and week 5, week 13 and week 24)
- Change from baseline PD symptoms at week 5, week 13 and week 24(at baseline and week 5, week 13 and week 24)
- Change from baseline anxiety at week 5, week 13 and week 24(at baseline and week 5, week 13 and week 24)