Bruggeman Arnout, Vandendriessche Charysse, Hamerlinck Hannelore, De Looze Danny, Tate David J, Vuylsteke Marnik, De Commer Lindsey, Devolder Lindsay, Raes Jeroen, Verhasselt Bruno, Laukens Debby, Vandenbroucke Roosmarijn E, Santens Patrick
Department of Neurology, University Hospital Ghent, Ghent, Belgium.
Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
EClinicalMedicine. 2024 Mar 27;71:102563. doi: 10.1016/j.eclinm.2024.102563. eCollection 2024 May.
Dysregulation of the gut microbiome has been implicated in Parkinson's disease (PD). This study aimed to evaluate the clinical effects and safety of a single faecal microbiota transplantation (FMT) in patients with early-stage PD.
The GUT-PARFECT trial, a single-centre randomised, double-blind, placebo-controlled trial was conducted at Ghent University Hospital between December 01, 2020 and December 12, 2022. Participants (aged 50-65 years, Hoehn and Yahr stage 2) were randomly assigned to receive nasojejunal FMT with either healthy donor stool or their own stool. Computer-generated randomisation was done in a 1:1 ratio through permutated-block scheduling. Treatment allocation was concealed for participants and investigators. The primary outcome measure at 12 months was the change in the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score obtained during off-medication evaluations. Intention-to-treat analysis was performed using a mixed model for repeated measures analysis. This completed trial is registered on ClinicalTrials.gov (NCT03808389).
Between December 2020 and December 2021, FMT procedures were conducted on 46 patients with PD: 22 in the healthy donor group and 24 in the placebo group. Clinical evaluations were performed at baseline, 3, 6, and 12 months post-FMT. Full data analysis was possible for 21 participants in the healthy donor group and 22 in the placebo group. After 12 months, the MDS-UPDRS motor score significantly improved by a mean of 5.8 points (95% CI -11.4 to -0.2) in the healthy donor group and by 2.7 points (-8.3 to 2.9) in the placebo group (p = 0.0235). Adverse events were limited to temporary abdominal discomfort.
Our findings suggested a single FMT induced mild, but long-lasting beneficial effects on motor symptoms in patients with early-stage PD. These findings highlight the potential of modulating the gut microbiome as a therapeutic approach and warrant a further exploration of FMT in larger cohorts of patients with PD in various disease stages.
Flemish PD patient organizations (VPL and Parkili), Research Foundation Flanders (FWO), Biocodex Microbiota Foundation.
肠道微生物群失调与帕金森病（PD）有关。本研究旨在评估单次粪便微生物群移植（FMT）对早期PD患者的临床疗效和安全性。
GUT - PARFECT试验是一项单中心随机、双盲、安慰剂对照试验，于2020年12月1日至2022年12月12日在根特大学医院进行。参与者（年龄50 - 65岁，Hoehn和Yahr分期为2期）被随机分配接受经鼻空肠FMT，分别使用健康供体粪便或自身粪便。通过排列块设计以1:1的比例进行计算机生成随机化。对参与者和研究者隐瞒治疗分配情况。12个月时的主要结局指标是在停药评估期间获得的运动障碍协会统一帕金森病评定量表（MDS - UPDRS）运动评分的变化。使用重复测量的混合模型进行意向性分析。该完成的试验已在ClinicalTrials.gov（NCT03808389）上注册。
2020年12月至2021年12月期间，对46例PD患者进行了FMT手术：健康供体组22例，安慰剂组24例。在FMT后基线、3个月、6个月和12个月进行临床评估。健康供体组21名参与者和安慰剂组22名参与者可进行完整数据分析。12个月后，健康供体组的MDS - UPDRS运动评分平均显著改善5.8分（95%CI -11.4至 -0.2），安慰剂组改善2.7分（-8.3至2.9）（p = 0.0235）。不良事件仅限于短暂的腹部不适。
我们的研究结果表明，单次FMT对早期PD患者的运动症状产生了轻微但持久的有益影响。这些发现凸显了调节肠道微生物群作为一种治疗方法的潜力，并值得在更大规模的不同疾病阶段的PD患者队列中进一步探索FMT。
佛兰芒PD患者组织（VPL和Parkili）、佛兰芒研究基金会（FWO）、Biocodex微生物群基金会。
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