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Cited by 145Parkinson's Disease Mechanisms and TreatmentsGut microbiota and healthGastrointestinal motility and disorders

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.

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

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Bruggeman, Arnout, Vandendriessche, Charysse, Hamerlinck, Hannelore, De Looze, Danny, Tate, David J., Vuylsteke, Marnik, De Commer, Lindsey, Devolder, Lindsay, Raes, Jeroen, Verhasselt, Bruno, Laukens, Debby, Vandenbroucke, Roosmarijn E., Santens, Patrick·2024·eClinicalMedicine
DOI 10.1016/j.eclinm.2024.102563PMC PMC11056595
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Abstract

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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Crossref · 10.1016/j.eclinm.2024.102563

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Fig. 1 Trial profile.
Fig. 1 Trial profile.CC BY-NC-ND · PubMed Central
Fig. 2 MDS-UPDRS part 3 motor scores (A) and changes in MDS-UPDRS part 3 motor scores (B), by study visit. Data are means for the off-medication state. Error bars represent standard error of the mean. MDS-UPDRS, Movement Disorders Society Unified Parkinson's Disease Rating Scale.
Fig. 2 MDS-UPDRS part 3 motor scores (A) and changes in MDS-UPDRS part 3 motor scores (B), by study visit. Data are means for the off-medication state. Error bars represent standard error of the mean. MDS-UPDRS, Movement Disorders Society Unified Parkinson's Disease Rating Scale.CC BY-NC-ND · PubMed Central
Fig. 3 Number of radiopaque pellets on day 7 (A) and changes in number of radiopaque pellets (B), by study visit. Higher number of radiopaque pellets correlates to slower colon transit as a marker for constipation (C, D). Data are means. Error bars represent standard error of the mean.
Fig. 3 Number of radiopaque pellets on day 7 (A) and changes in number of radiopaque pellets (B), by study visit. Higher number of radiopaque pellets correlates to slower colon transit as a marker for constipation (C, D). Data are means. Error bars represent standard error of the mean.CC BY-NC-ND · PubMed Central

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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)
DOI
10.1016/j.eclinm.2024.102563
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
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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