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.
“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]
The Results section (page unavailable) says participants were followed through week 12, not six months, and reports a significantly larger decrease in the MDS-UPDRS total score in the FMT arm than in the placebo arm at week 12. The cited passages do not report smaller medication-dose increases in the FMT arm. (LLM, conf=0.86)
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Experimental — accuracy not yet measuredThe FMT treatment failed to produce a significant change in the gut microbiome in that study.
“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]
The Results section on metagenomic sequencing (page unavailable) says gut-microbiota alpha and beta diversity did not change significantly after FMT or placebo, supporting the narrower point about diversity. It does not report the cited 3% versus 33% dysbiosis-status figures, and it reports differences in microbial species and community networks among FMT responders, so the broader claim of no significant microbiome change is overstated. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn these studies, the clinical findings were associated with a shift toward anti-inflammatory microbial species.
“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]
There are currently four RCTs with available evidence for the role of FMT in treating PD.
“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]
Three of these RCTs 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.
“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]
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.
“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]
The Results sections on gut microbiota composition and metagenomic sequencing discuss microbial differences, but do not report patients changing from dysbiotic to non-dysbiotic status. Searches for that transition and the claimed 3% and 33% figures found no matching passage in our copy; the reported percentages therefore cannot be verified from this source. (LLM, conf=0.76)
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Parkinson's Disease: The Epidemiology, Risk Factors, Molecular Pathogenesis, Prevention, and Therapy
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Gut Microbiome and Its Role in Parkinson's Disease
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Gut–Brain Axis and Brain Microbiome Interactions from a Medical Perspective
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Fecal microbiota transplantation-current perspective on human health
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Herbal Interventions in Parkinson’s Disease: A Systematic Review of Preclinical Studies
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Gut–brain axis in health and brain disease
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The role of the gut microbiota in neuropsychiatric disorders and therapy
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Fecal microbiota transplantation for Parkinson's disease: A systematic review of clinical evidence
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Gut microbiota and sepsis-associated encephalopathy: pathogenesis and precision therapies
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Targeting gut microbiota as a therapeutic approach for neurodegenerative diseases
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Gut Microbiome as a Source of Probiotic Drugs for Parkinson’s Disease
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Faecal microbiota transplant for Parkinson’s disease: promises and future directions
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Fecal Microbiome Transplants For Parkinson Disease
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The Enteric Nervous System as a Mediator of Microbiota‐Gut‐Brain Interactions in Parkinson's Disease
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The role of the gut microbiome in Parkinson’s disease
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Age-driven dysbiosis: gut microbiota in the pathogenesis and treatment of aging disorders
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Research progress on natural products in regulating the gut microbiota in Parkinson’s disease
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Self-citationRole of the Intestinal Microbiota in the Molecular Pathogenesis of Atypical Parkinsonian Syndromes
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Enteric nervous system as a therapeutic target in gastrointestinal disorders
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Microbiome-based biomarkers to guide personalized microbiome-based therapies for Parkinson’s diseasePreprint
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- 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 › 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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