FMT Parkinson’s Symptoms Not Improved by Fecal Transplant (Jul 2024, n=45) Fecal Microbiota Transplantation for Treatment of Parkinson Disease. A Randomized Clinical Trial

Fecal Microbiota Transplants

Michael Harrop

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https://www.insideprecisionmedicine.com/topics/patient-care/parkinsons-symptoms-not-improved-by-fecal-transplant/
https://jamanetwork.com/journals/jamaneurology/article-abstract/2821254

Key Points​

Question Is fecal microbiota transplantation (FMT) safe and does it improve symptoms in Parkinson disease (PD)?

Findings In this randomized clinical trial including 45 patients with PD, FMT was linked to mostly transient gastrointestinal adverse events without clinically meaningful improvements; in the placebo group, dopaminergic medication increased faster, and there was some clinical improvement. While FMT induced stronger, donor dependent, microbiota changes, dysbiosis resolved more frequently after placebo.

Meaning FMT was safe but did not improve PD symptoms more than placebo; improvements and microbiome changes after placebo warrant further research on FMT and bowel cleansing in PD.

Abstract​


Importance Dysbiosis has been robustly demonstrated in Parkinson disease (PD), and fecal microbiota transplantation (FMT) has shown promising effects in preclinical PD models.

Objective To assess the safety and symptomatic efficacy of colonic single-dose anaerobically prepared FMT.

Design, Setting, and Participants This 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.

Intervention Participants were randomized in a 2:1 ratio to receive FMT or placebo via colonoscopy.

Main Outcomes and Measures The 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).

Results
The 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 Relevance FMT 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.

I don't have access to the full study, but this poor result was almost certainly due to the widespread donor-quality deficiencies.
 
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