ImportanceDysbiosis has been robustly demonstrated in Parkinson disease (PD), and fecal microbiota transplantation (FMT) has shown promising effects in preclinical PD models.ObjectiveTo assess the safety and symptomatic efficacy of colonic single-dose anaerobically prepared FMT.Design, Setting, and ParticipantsThis was a double-blind, placebo-controlled, randomized clinical trial conducted between November 2020 and June 2023 with a follow-up period of 12 months at 4 hospitals in Finland. Patients with PD aged 35 to 75 years in Hoehn & Yahr stage 1-3 with a mild to moderate symptom burden and dysbiosis of fecal microbiota were included. Of 229 patients screened, 48 were randomized and 47 received the intervention. One patient discontinued due to worsening of PD symptoms. Two further patients were excluded before analysis and 45 were included in the intention-to-treat analysis.InterventionParticipants were randomized in a 2:1 ratio to receive FMT or placebo via colonoscopy.Main Outcomes and MeasuresThe primary end point was the change of Movement Disorder Society Unified Parkinson’s Disease Rating Scale parts I-III (part III off medication) at 6 months. Safety was assessed by recording adverse events (AEs).ResultsThe median (IQR) age was 65 (52.5-70.0) years in the placebo group and 66 (59.25-69.75) years in the FMT group; 9 (60.0%) and 16 (53.3%) patients were male in the placebo group and the FMT group, respectively. The primary outcome did not differ between the groups (0.97 points, 95% CI, −5.10 to 7.03, P = .75). Gastrointestinal AEs were more frequent in the FMT group (16 [53%] vs 1 [7%]; P = .003). Secondary outcomes and post hoc analyses showed stronger increase of dopaminergic medication and improvement of certain motor and nonmotor outcomes in the placebo group. Microbiota changes were more pronounced after FMT but differed by donor. Nevertheless, dysbiosis status was reversed more frequently in the placebo group.Conclusions and RelevanceFMT was safe but did not offer clinically meaningful improvements. Further studies—for example, through modified FMT approaches or bowel cleansing—are warranted regarding the specific impact of donor microbiota composition and dysbiosis conversion on motor and nonmotor outcomes as well as medication needs in PD.Trial RegistrationClinicalTrials.gov Identifier: NCT04854291

中文翻译：

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粪便微生物移植治疗帕金森病


重要性生态失调已在帕金森病 (PD) 中得到充分证明，粪便微生物群移植 (FMT) 在临床前 PD 模型中显示出良好的效果。目的评估结肠单剂量厌氧制备的 FMT 的安全性和症状疗效。设计、设置和参与者这是一项双盲、安慰剂对照、随机临床试验，于 2020 年 11 月至 2023 年 6 月期间在芬兰 4 家医院进行，随访期为 12 个月。 Hoehn & 医院年龄 35 至 75 岁的 PD 患者Yahr 1-3 阶段包括轻度至中度症状负担和粪便微生物群失调。在筛选的 229 名患者中，48 人被随机分配，47 人接受干预。一名患者因 PD 症状恶化而停药。在分析前另外排除了两名患者，并纳入了 45 名患者进行意向治疗分析。干预参与者以 2:1 的比例随机分配，通过结肠镜检查接受 FMT 或安慰剂。主要结果和措施主要终点是运动障碍的变化6 个月时学会统一帕金森病评定量表 I-III 部分（停药后的第 III 部分）。通过记录不良事件（AE）来评估安全性。结果安慰剂组的中位（IQR）年龄为65（52.5-70.0）岁，FMT组为66（59.25-69.75）岁；安慰剂组和 FMT 组分别有 9 名 (60.0%) 和 16 名 (53.3%) 患者为男性。各组之间的主要结局没有差异（0.97 分，95% CI，-5.10 至 7.03，P = .75）。 FMT 组的胃肠道 AE 更为常见（16 例 [53%] vs 1 例 [7%]；P = .003）。 次要结果和事后分析显示，安慰剂组中多巴胺能药物的增加更加明显，并且某些运动和非运动结果得到改善。 FMT 后微​​生物群的变化更加明显，但因捐赠者而异。然而，安慰剂组中菌群失调状态更频繁地逆转。结论和相关性FMT 是安全的，但没有提供有临床意义的改善。需要进一步研究——例如，通过改进的 FMT 方法或肠道清洁——来了解供体微生物群组成和菌群失调转化对运动和非运动结果以及 PD 中药物需求的具体影响。试验注册临床试验。政府标识符：NCT04854291