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Fecal Microbiota Transplantation for Treatment of Parkinson Disease: A Randomized Clinical Trial
Open accessAbstract
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. Trial Registration: ClinicalTrials.gov Identifier: NCT04854291
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In the citing paper
“There are currently four RCTs with available evidence for the role of FMT in treating PD [206–209].”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [206]
In the citing paper
“Three of these reported changes in global or motor function, and of these two reported significant improvement UPDRS PD symptom scores at 12 weeks and 12 months, respectively.”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [206]
In the citing paper
“One study reported no changes in motor function at 6 months post-FMT, although here the treatment group required smaller dose increases than placebo.”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [206]
In the citing paper
“In these studies, the clinical findings were associated with a shift toward anti-inflammatory microbial species.”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [206]
In the citing paper
“In this study, only 3% of the treatment group were reported to show a change from dysbiotic to non-dysbiotic status, compared to 33% in the placebo arm, suggesting that the FMT treatment failed to produce a significant change in the gut microbiome.”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [206]
In the citing paper
“In this study, only 3% of the treatment group were reported to show a change from dysbiotic to non-dysbiotic status, compared to 33% in the placebo arm, suggesting that the FMT treatment failed to produce a significant change in the gut microbiome.”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [206]
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Metadata
- Authors
- Scheperjans, F., Levo, R., Bosch, B., Lääperi, M., Pereira, P. A. B., Smolander, O.-P., Aho, V. T. E., Vetkas, N., Toivio, L., Kainulainen, V., Fedorova, T. D., Lahtinen, P., Ortiz, R., Kaasinen, V., Satokari, R., & Arkkila, P.
- Affiliations
- University of Helsinki (FI)
- Helsinki University Hospital (FI)
- Lääperi Statistical Consulting, Helsinki, Finland
- Aarhus University (DK)
- Päijät-Hämeen Keskussairaala (FI)
- Tampere University Hospital (FI)
- University of Turku (FI)
- Corresponding author
- Scheperjans, Filip
- ORCID
- Venue
- JAMA Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2024-09-01
- Volume
- 81
- Issue
- 9
- Pages
- 925
- ISSN
- 2168-6149 (ISSN-L)
- OpenAlex
- W4401075949
- Cited by
- 128
- References
- 47
- Citations by year
- 2026: 58 · 2025: 60 · 2024: 10
- FWCI
- 34.25
- Type
- journal article
- Language
- en
- Open access
- green
- pmc.ncbi.nlm.nih.gov
- Locations
- JAMA Neurology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion)
- Tampere University Institutional Repository (Tampere University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Parkinson's Disease Mechanisms and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- fecal microbiota transplantation, Parkinson's disease, gut dysbiosis, microbiota, MDS-UPDRS, motor symptoms, non-motor symptoms, dopaminergic therapy, gastrointestinal adverse effects, donor microbiota, treatment safety, treatment efficacy, bowel preparation
- MeSH terms
- Fecal Microbiota Transplantation, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Parkinson Disease, Treatment Outcome, Dysbiosis
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