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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
Open accessAbstract
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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“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 [209]
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“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 [209]
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“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 [209]
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“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 [209]
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“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 [209]
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“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 [209]
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Metadata
- Authors
- Bruggeman, A., Vandendriessche, C., Hamerlinck, H., De Looze, D., Tate, D. J., Vuylsteke, M., De Commer, L., Devolder, L., Raes, J., Verhasselt, B., Laukens, D., Vandenbroucke, R. E., & Santens, P.
- Affiliations
- Ghent University Hospital (BE)
- Ghent University (BE)
- VIB-UGent Center for Inflammation Research (BE)
- Rega Institute for Medical Research (BE)
- Corresponding author
- Santens, Patrick
- ORCID
- Venue
- eClinicalMedicine
- Publisher
- Elsevier BV
- Published
- 2024-05
- Volume
- 71
- Pages
- 102563
- ISSN
- 2589-5370 (ISSN-L)
- PMC
- PMC11056595
- OpenAlex
- W4393224953
- Cited by
- 139
- References
- 32
- Citations by year
- 2026: 48 · 2025: 71 · 2024: 20
- FWCI
- 37.19
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- EClinicalMedicine (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, cc-by-nc-nd)
- Lirias (KU Leuven) (submittedVersion, cc-by-nc-nd)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Biocodex Microbiota Foundation
- Fonds Wetenschappelijk Onderzoek (1295223N, T000819N)
- 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, early-stage Parkinson's disease, gut microbiota, motor symptoms, treatment safety, adverse events, microbiota-based therapy
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