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Cited by 162Parkinson's Disease Mechanisms and TreatmentsGut microbiota and healthGastrointestinal motility and disorders

Fecal microbiota transplantation in Parkinson's disease—A randomized repeat-dose, placebo-controlled clinical pilot study

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DuPont, Herbert L., Suescun, Jessika, Jiang, Zhi-Dong, Brown, Eric L., Essigmann, Heather T., Alexander, Ashley S., DuPont, Andrew W., Iqbal, Tehseen +3 more·2023·Frontiers in Neurology
DOI 10.3389/fneur.2023.1104759PMC PMC10019775
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Abstract

Background and purpose: The intestinal microbiome plays a primary role in the pathogenesis of neurodegenerative disorders and may provide an opportunity for disease modification. We performed a pilot clinical study looking at the safety of fecal microbiota transplantation (FMT), its effect on the microbiome, and improvement of symptoms in Parkinson's disease. Methods: This was a randomized, double-blind placebo-controlled pilot study, wherein orally administered lyophilized FMT product or matching placebo was given to 12 subjects with mild to moderate Parkinson's disease with constipation twice weekly for 12 weeks. Subjects were followed for safety and clinical improvement for 9 additional months (total study duration 12 months). Results: Fecal microbiota transplantation caused non-severe transient upper gastrointestinal symptoms. One subject receiving FMT was diagnosed with unrelated metastatic cancer and was removed from the trial. Beta diversity (taxa) of the microbiome, was similar comparing placebo and FMT groups at baseline, however, for subjects randomized to FMT, it increased significantly at 6 weeks ( p = 0.008) and 13 weeks ( p = 0.0008). After treatment with FMT, proportions of selective families within the phylum Firmicutes increased significantly, while proportion of microbiota belonging to Proteobacteria were significantly reduced. Objective motor findings showed only temporary improvement while subjective symptom improvements were reported compared to baseline in the group receiving FMT. Constipation, gut transient times (NS), and gut motility index ( p = 0.0374) were improved in the FMT group. Conclusions: Subjects with Parkinson's disease tolerated multi-dose-FMT, and experienced increased diversity of the intestinal microbiome that was associated with reduction in constipation and improved gut transit and intestinal motility. Fecal microbiota transplantation administration improved subjective motor and non-motor symptoms. Clinical trial registration: ClinicalTrial.gov , identifier: NCT03671785.

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  • The 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 [208]

    The Results (Primary endpoints; page unavailable) report significant differences between the FMT and placebo groups in microbiome beta diversity at 6 weeks (p = 0.008) and 13 weeks (p = 0.0008), as well as significant differences in bacterial families at 13 weeks. The Discussion likewise says beta diversity increased significantly in the FMT group. The copy does not report the claimed 3% versus 33% change from dysbiotic to non-dysbiotic status. (LLM, conf=0.90)

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  • 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 [208]

    The Methods (Subject monitoring; page unavailable) say this randomized pilot study assessed UPDRS, and the Results (Exploratory efficacy end points; page unavailable) report significant subjective improvement in motor deficits and overall Parkinson’s symptoms at 12 weeks using a visual analog scale. That is not a finding of significant improvement in UPDRS scores; the Discussion describes objective motor improvement as transient and occurring in both groups. This single study also does not establish the sentence’s count of three RCTs or a 12-month result. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • In 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 [208]

    The Results and Discussion (pages unavailable) report clinical improvement after FMT alongside increases in bacterial families described as beneficial and a decrease in proinflammatory Proteobacteriaceae. They do not establish that the clinical findings were specifically associated with anti-inflammatory species; the reported microbial comparisons are primarily at the family level. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • 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 [208]

    The Discussion (page unavailable) reports only transient objective motor improvement, which supports the general point that improvement was not sustained. It does not establish the specific six-month finding. Table 1 in Results gives baseline levodopa doses, but the passages found do not report smaller subsequent dose increases in the FMT group than in the placebo group. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

  • 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 [208]

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Authors
DuPont, H. L., Suescun, J., Jiang, Z.-D., Brown, E. L., Essigmann, H. T., Alexander, A. S., DuPont, A. W., Iqbal, T., Utay, N. S., Newmark, M., & Schiess, M. C.
Affiliations
  • Kelsey-Seybold Clinic (US)
  • Kelsey Research Foundation (US)
  • The University of Texas Southwestern Medical Center (US)
Corresponding author
DuPont, Herbert L.
ORCID
Venue
Frontiers in Neurology
Publisher
Frontiers Media SA
Published
2023-03-02
Volume
14
Pages
1104759-1104759
ISSN
1664-2295 (ISSN-L)
DOI
10.3389/fneur.2023.1104759
PMC
PMC10019775
OpenAlex
W4322772752
Cited by
162
References
15
Citations by year
2026: 39 · 2025: 54 · 2024: 56 · 2023: 13
FWCI
27.56
Type
journal article
Language
en
Open access
Licence
Locations
  • Frontiers in Neurology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Digital Commons-TMC (Texas Medical Center) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • International Parkinson and Movement Disorder Society
  • University of Texas Health Science Center at Houston
  • University of Texas MD Anderson Cancer Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (P30DK056338)
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 microbiota, constipation, intestinal motility, beta diversity, Firmicutes, Proteobacteria, motor symptoms, non-motor symptoms, safety, neurodegeneration

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