Faecal microbiota transplant in Parkinson’s disease: pilot study to establish safety & tolerability (Jul 2025, n=12, enema over 6 mo, Biomebank) No significant motor symptom changes. No sustained improvement in non-motor symptoms. FMT

[Michael Harrop]

https://www.nature.com/articles/s41531-025-01061-5

Australian group that used the TGA-approved, GMP stool bank.

Abstract​

Emerging evidence suggests gut microbiota differences in Parkinson’s Disease (PD) may impact disease progression and treatment. Faecal Microbiota Transplantation (FMT) offers a potential therapeutic approach.

We conducted an open-label pilot study to assess the safety, tolerability, and symptom impact of FMT in 12 patients with mild to moderate PD, administered via enema for 6 months.

FMT was safe and well tolerated, causing only mild, transient gastrointestinal symptoms. While no significant motor symptom changes were observed, there was a trend toward reduced daily OFF time at 2 months. Whilst no sustained improvement in non-motor symptoms was found after 6 months, transient improvements in quality of life and non-motor scores were noted at 2 months; these gains regressed by study end.

Overall, extended FMT therapy in PD appears safe and tolerable, with reduction in daily motor OFF time and self-reported non-motor symptoms that was not sustained throughout the 6-months of treatment

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FMT enemas were sourced from Biomebank, a Therapeutic Goods Administration (TGA)-accredited provider based in South Australia (ARTG #399066). The FMT donor screening, collection, and manufacturing followed the standards outlined in Therapeutic Goods Order No. 105 – Standards for FMT18. The FMT was administered by a clinical nurse as a 50 mL enema containing 12.5 g of donor faeces. Subjects were instructed to retain the FMT for at least 30 min in the right lateral position. The intervention consisted of an induction phase with 6 donor FMT enemas over 8 weeks (weeks 0, 1, 2, 3, 5, 7), followed by a maintenance phase with 4 monthly donor FMT enemas over 4 months (months 3, 4, 5, 6), totalling 6 months of FMT therapy.

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More evidence that GMP stool banks are not valid approaches to FMT.