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Efficacy of fecal microbiota transplantation in patients with Parkinson’s disease: clinical trial results from a randomized, placebo-controlled design
Open accessAbstract
The occurrence and development of Parkinson’s disease (PD) have been demonstrated to be related to gut dysbiosis, however, the impact of fecal microbiota transplantation (FMT) on microbiota engraftment in PD patients is uncertain. We performed a randomized, placebo-controlled trial at the Department of Neurology, Army Medical University Southwest Hospital in China (ChiCTR1900021405) from February 2019 to December 2019. Fifty-six participants with mild to moderate PD (Hoehn-Yahr stage 1–3) were randomly assigned to the FMT and placebo group, 27 patients in the FMT group and 27 in the placebo group completed the whole trial. During the follow-up, no severe adverse effect was observed, and patients with FMT treatment showed significant improvement in PD-related autonomic symptoms compared with the placebo group at the end of this trial (MDS-UPDRS total score, group×time effect, B = -6.56 [−12.98, −0.13], P < 0.05). Additionally, FMT improved gastrointestinal disorders and a marked increase in the complexity of the microecological system in patients. This study demonstrated that FMT through oral administration is clinically feasible and has the potential to improve the effectiveness of current medications in the clinical symptoms of PD patients.
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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 [207]
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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 [207]
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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 [207]
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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 [207]
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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 [207]
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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 [207]
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Metadata
- Authors
- Cheng, Y., Tan, G., Zhu, Q., Wang, C., Ruan, G., Ying, S., Qie, J., Hu, X., Xiao, Z., Xu, F., Chen, L., Chen, M., Pei, Y., Zhang, H., Tian, Y., Chen, D., Liu, X., Huang, H., & Wei, Y.
- Affiliations
- Army Medical University (CN)
- Suzhou Municipal Hospital (CN)
- Department of Pathogen Biology-Microbiology Division, Key Laboratory of Pathogen of Jiangsu Province; The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital Gusu School, Nanjing Medical University, Jiangsu, China
- Corresponding author
- Liu, Xingyin
- Huang, Heqing
- Wei, Yanling
- ORCID
- Venue
- Gut Microbes
- Publisher
- Informa UK Limited
- Published
- 2023-12-06
- Volume
- 15
- Issue
- 2
- Pages
- 2284247-2284247
- ISSN
- 1949-0976 (ISSN-L)
- 1949-0984
- PMC
- PMC10841011
- OpenAlex
- W4389451466
- Cited by
- 147
- References
- 53
- Citations by year
- 2026: 42 · 2025: 73 · 2024: 32
- FWCI
- 25.01
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Gut Microbes (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- the National Natural Science Foundation of China (82172288)
- the Special Project for Enhancement of Science and Technology Innovation Capability of Army Medical University (2019XLC3040)
- 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, autonomic symptoms, gastrointestinal diseases, MDS-UPDRS, oral administration, treatment feasibility
- MeSH terms
- Gastrointestinal Microbiome, Fecal Microbiota Transplantation, China, Feces, Humans, Parkinson Disease, Treatment Outcome, Dysbiosis
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