FMT Fecal microbiota transplant eases Parkinson’s symptoms (Mar 2024, n=46) Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial

[Michael Harrop]

https://parkinsonsnewstoday.com/news/fecal-microbiota-transplant-eases-parkinsons-symptoms-trial/
https://www.sciencedirect.com/science/article/pii/S2589537024001421

Summary​

Background​

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.

Methods​

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
).

Findings​

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.

Interpretation​

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.

Funding​

Flemish PD patient organizations (VPL and Parkili), Research Foundation Flanders (FWO), Biocodex Microbiota Foundation.

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Healthy donors were recruited via the Ghent Stool Bank following a strict inclusion protocol according to national (Superior Health Council of Belgium nr. 9202) and international guidelines (European FMT working group).21 The selection process involves a meticulous review of the donor's clinical and personal information (collected through a questionnaire) as well as serology and stool testing.

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Standard, poor donor quality. Stool type not even considered.

FMT solutions of 17 different healthy donors were used in the study.

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0% chance they found 17 high-quality donors.

For each FMT preparation, 50 g of faecal product was used. The faecal product was diluted with sterile saline and subsequently homogenized anaerobically and filtered using a stomacher (BagMixer, Interscience). Glycerol (10%) was added as a cryoprotectant to the filtered product resulting in a total volume of 200 ml. The faecal suspension was stored at −80 °C. Maximum 4 h before the FMT, the faecal suspension was thawed for 30 min in a water bath at 37 °C.

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For FMT, candidates underwent this bowel preparation again. The FMT solution was thawed at 37 °C prior to the FMT procedure. The transplantation itself was performed through nasojejunal administration.

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[Doreen2800]

A couple Year's ago I had a patient who had Parkinson's, her diet was mostly finger foods, so she was given sandwiches. Her husband was upset and placed her on a strict high vegetable and fruit diet. Within A year she was taken out of the nursing home setting and able to live with him in the assisted living setting. I was curious, so I asked her nurse about medication and dosage changes. She told me nothing had changed this year. It was amazing to see this woman walk with improved flexibility , when it was such a difficult task for her just a year ago. So, I do believe gut flora really plays an important role in Parkinson's disease progression.