Fecal Microbiota Transplantation in Parkinson's Disease.

NCT07597421 | Not Yet Recruiting

• 1 other identifier: 202401790A0
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fecal microbiota transplantation (FMT) is an effective and safe treatment for Clostridioides difficile infection (CDI). Though CDI is the only indication for FMT, more and more preliminary data on FMT in neurological disorders are reported due to gut-brain axis. This study is a pilot study to apply FMT on patients with Parkinson's disease (PD). The effect of FMT on motor and non-motor symptoms in PD will be also evaluated.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  The improvement of the motor section scores of MDS-UPDRS in an off- medication state, from baseline to 6 months post-FMT for the treatment group compared to the control group.

  6 months

Secondary Outcomes (1)

• Secondary endpoints

  6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

In the experimental group, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed. Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT. Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months.

Procedure: Fecal microbiota transplantation

Control Group

ACTIVE COMPARATOR

In the control group, all the assessments will be conducted at the baseline, 3 months, and 6 months. Stool samples will be collected at baseline, 3 months, and 6 months.

Procedure: Not received Fecal microbiota transplantation

Interventions

Fecal microbiota transplantation PROCEDURE

All subjects in the treatment group will receive FMT once. Recipients must adhere to a low-fiber diet for three days, and pre-treatment antibiotics with Vancomycin 125 mg, administered as 2 capsules every 6 hours for 3 days. After a 24-hour washout period, they underwent colon preparation followed by FMT. During the procedure, processed 250cc microbiota fluid from healthy donors, provided by the Chang Gung fecal bank, was administered into the terminal ileum or cecum via ileocolonoscopy. To ensure safety and traceability, only a single-donor microbiota is used. After FMT, patients were instructed to lie on their right side for at least 30 minutes.

Experimental Group

Not received Fecal microbiota transplantation PROCEDURE

All subjects in the Control group will not receive FMT.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of idiopathic PD according to UK brain bank criteria.
• PD disease duration ≧5 years to avoid the possible misdiagnosis of atypical parkinsonism.
• Hoehn-Yahr stage 1-4
• Using levodopa in a currently fixed dose.
• Presence of motor complications (motor fluctuation or dyskinesia).
• Written informed consent.
• Age above 18.

You may not qualify if:

• Hoehn-Yahr stage 5. (wheelchair ridden or bedridden due to PD)
• Dementia (MMSE\<24), history of encephalitis, or brain organic lesions, including congenital or acquired structural abnormalities (which were detected through brain computed tomography scan or Magnetic Resonance Imaging) may affect neurological function, leading to various neurological deficits and mpairing the cognitive function.
• Current use of probiotics or in the past 3 months.
• For women with childbearing potential. (Female participants are suggested to prevent pregnancy during this trial and undergo a pregnancy test before enrollment.)
• Current need of antibiotics or use in the previous 3 months.
• End stage renal disease caused uremic encephalopathy or liver cirrhosis caused hepatic encephalopathy
• Immunocompromised state.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (30)

• Savica R, Carlin JM, Grossardt BR, Bower JH, Ahlskog JE, Maraganore DM, Bharucha AE, Rocca WA. Medical records documentation of constipation preceding Parkinson disease: A case-control study. Neurology. 2009 Nov 24;73(21):1752-8. doi: 10.1212/WNL.0b013e3181c34af5.

  PMID: 19933976 BACKGROUND

• Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.

  PMID: 9278044 BACKGROUND

• Hilton D, Stephens M, Kirk L, Edwards P, Potter R, Zajicek J, Broughton E, Hagan H, Carroll C. Accumulation of alpha-synuclein in the bowel of patients in the pre-clinical phase of Parkinson's disease. Acta Neuropathol. 2014 Feb;127(2):235-41. doi: 10.1007/s00401-013-1214-6. Epub 2013 Nov 17.

  PMID: 24240814 BACKGROUND

• Shannon KM, Keshavarzian A, Dodiya HB, Jakate S, Kordower JH. Is alpha-synuclein in the colon a biomarker for premotor Parkinson's disease? Evidence from 3 cases. Mov Disord. 2012 May;27(6):716-9. doi: 10.1002/mds.25020. Epub 2012 May 1.

  PMID: 22550057 BACKGROUND

• Sprenger FS, Stefanova N, Gelpi E, Seppi K, Navarro-Otano J, Offner F, Vilas D, Valldeoriola F, Pont-Sunyer C, Aldecoa I, Gaig C, Gines A, Cuatrecasas M, Hogl B, Frauscher B, Iranzo A, Wenning GK, Vogel W, Tolosa E, Poewe W. Enteric nervous system alpha-synuclein immunoreactivity in idiopathic REM sleep behavior disorder. Neurology. 2015 Nov 17;85(20):1761-8. doi: 10.1212/WNL.0000000000002126. Epub 2015 Oct 16.

  PMID: 26475692 BACKGROUND

• Stokholm MG, Danielsen EH, Hamilton-Dutoit SJ, Borghammer P. Pathological alpha-synuclein in gastrointestinal tissues from prodromal Parkinson disease patients. Ann Neurol. 2016 Jun;79(6):940-9. doi: 10.1002/ana.24648. Epub 2016 Apr 9.

  PMID: 27015771 BACKGROUND

• Liu B, Fang F, Pedersen NL, Tillander A, Ludvigsson JF, Ekbom A, Svenningsson P, Chen H, Wirdefeldt K. Vagotomy and Parkinson disease: A Swedish register-based matched-cohort study. Neurology. 2017 May 23;88(21):1996-2002. doi: 10.1212/WNL.0000000000003961. Epub 2017 Apr 26.

  PMID: 28446653 BACKGROUND

• Svensson E, Horvath-Puho E, Thomsen RW, Djurhuus JC, Pedersen L, Borghammer P, Sorensen HT. Vagotomy and subsequent risk of Parkinson's disease. Ann Neurol. 2015 Oct;78(4):522-9. doi: 10.1002/ana.24448. Epub 2015 Jul 17.

  PMID: 26031848 BACKGROUND

• Kim S, Kwon SH, Kam TI, Panicker N, Karuppagounder SS, Lee S, Lee JH, Kim WR, Kook M, Foss CA, Shen C, Lee H, Kulkarni S, Pasricha PJ, Lee G, Pomper MG, Dawson VL, Dawson TM, Ko HS. Transneuronal Propagation of Pathologic alpha-Synuclein from the Gut to the Brain Models Parkinson's Disease. Neuron. 2019 Aug 21;103(4):627-641.e7. doi: 10.1016/j.neuron.2019.05.035. Epub 2019 Jun 26.

  PMID: 31255487 BACKGROUND

• Cryan JF, O'Riordan KJ, Sandhu K, Peterson V, Dinan TG. The gut microbiome in neurological disorders. Lancet Neurol. 2020 Feb;19(2):179-194. doi: 10.1016/S1474-4422(19)30356-4. Epub 2019 Nov 18.

  PMID: 31753762 BACKGROUND

• Aho VTE, Houser MC, Pereira PAB, Chang J, Rudi K, Paulin L, Hertzberg V, Auvinen P, Tansey MG, Scheperjans F. Relationships of gut microbiota, short-chain fatty acids, inflammation, and the gut barrier in Parkinson's disease. Mol Neurodegener. 2021 Feb 8;16(1):6. doi: 10.1186/s13024-021-00427-6.

  PMID: 33557896 BACKGROUND

• Forsyth CB, Shannon KM, Kordower JH, Voigt RM, Shaikh M, Jaglin JA, Estes JD, Dodiya HB, Keshavarzian A. Increased intestinal permeability correlates with sigmoid mucosa alpha-synuclein staining and endotoxin exposure markers in early Parkinson's disease. PLoS One. 2011;6(12):e28032. doi: 10.1371/journal.pone.0028032. Epub 2011 Dec 1.

  PMID: 22145021 BACKGROUND

• Mulak A, Koszewicz M, Panek-Jeziorna M, Koziorowska-Gawron E, Budrewicz S. Fecal Calprotectin as a Marker of the Gut Immune System Activation Is Elevated in Parkinson's Disease. Front Neurosci. 2019 Sep 27;13:992. doi: 10.3389/fnins.2019.00992. eCollection 2019.

  PMID: 31611762 BACKGROUND

• Perez-Pardo P, Dodiya HB, Engen PA, Forsyth CB, Huschens AM, Shaikh M, Voigt RM, Naqib A, Green SJ, Kordower JH, Shannon KM, Garssen J, Kraneveld AD, Keshavarzian A. Role of TLR4 in the gut-brain axis in Parkinson's disease: a translational study from men to mice. Gut. 2019 May;68(5):829-843. doi: 10.1136/gutjnl-2018-316844. Epub 2018 Dec 15.

  PMID: 30554160 BACKGROUND

• Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.

  PMID: 29454662 BACKGROUND

• Matheoud D, Cannon T, Voisin A, Penttinen AM, Ramet L, Fahmy AM, Ducrot C, Laplante A, Bourque MJ, Zhu L, Cayrol R, Le Campion A, McBride HM, Gruenheid S, Trudeau LE, Desjardins M. Intestinal infection triggers Parkinson's disease-like symptoms in Pink1-/- mice. Nature. 2019 Jul;571(7766):565-569. doi: 10.1038/s41586-019-1405-y. Epub 2019 Jul 17.

  PMID: 31316206 BACKGROUND

• Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.

  PMID: 27912057 BACKGROUND

• Sun MF, Zhu YL, Zhou ZL, Jia XB, Xu YD, Yang Q, Cui C, Shen YQ. Neuroprotective effects of fecal microbiota transplantation on MPTP-induced Parkinson's disease mice: Gut microbiota, glial reaction and TLR4/TNF-alpha signaling pathway. Brain Behav Immun. 2018 May;70:48-60. doi: 10.1016/j.bbi.2018.02.005. Epub 2018 Feb 20.

  PMID: 29471030 BACKGROUND

• Gasbarrini A, Lauritano EC, Gabrielli M, Scarpellini E, Lupascu A, Ojetti V, Gasbarrini G. Small intestinal bacterial overgrowth: diagnosis and treatment. Dig Dis. 2007;25(3):237-40. doi: 10.1159/000103892.

  PMID: 17827947 BACKGROUND

• Losurdo G, Salvatore D'Abramo F, Indellicati G, Lillo C, Ierardi E, Di Leo A. The Influence of Small Intestinal Bacterial Overgrowth in Digestive and Extra-Intestinal Disorders. Int J Mol Sci. 2020 May 16;21(10):3531. doi: 10.3390/ijms21103531.

  PMID: 32429454 BACKGROUND

• Palacios N, Hannoun A, Flahive J, Ward D, Goostrey K, Deb A, Smith KM. Effect of Levodopa Initiation on the Gut Microbiota in Parkinson's Disease. Front Neurol. 2021 Mar 4;12:574529. doi: 10.3389/fneur.2021.574529. eCollection 2021.

  PMID: 33746867 BACKGROUND

• Solch RJ, Aigbogun JO, Voyiadjis AG, Talkington GM, Darensbourg RM, O'Connell S, Pickett KM, Perez SR, Maraganore DM. Mediterranean diet adherence, gut microbiota, and Alzheimer's or Parkinson's disease risk: A systematic review. J Neurol Sci. 2022 Mar 15;434:120166. doi: 10.1016/j.jns.2022.120166. Epub 2022 Jan 26.

  PMID: 35144237 BACKGROUND

• Hall DA, Voigt RM, Cantu-Jungles TM, Hamaker B, Engen PA, Shaikh M, Raeisi S, Green SJ, Naqib A, Forsyth CB, Chen T, Manfready R, Ouyang B, Rasmussen HE, Sedghi S, Goetz CG, Keshavarzian A. An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants. Nat Commun. 2023 Feb 18;14(1):926. doi: 10.1038/s41467-023-36497-x.

  PMID: 36801916 BACKGROUND

• Song Y, Garg S, Girotra M, Maddox C, von Rosenvinge EC, Dutta A, Dutta S, Fricke WF. Microbiota dynamics in patients treated with fecal microbiota transplantation for recurrent Clostridium difficile infection. PLoS One. 2013 Nov 26;8(11):e81330. doi: 10.1371/journal.pone.0081330. eCollection 2013.

  PMID: 24303043 BACKGROUND

• Weingarden AR, Chen C, Bobr A, Yao D, Lu Y, Nelson VM, Sadowsky MJ, Khoruts A. Microbiota transplantation restores normal fecal bile acid composition in recurrent Clostridium difficile infection. Am J Physiol Gastrointest Liver Physiol. 2014 Feb 15;306(4):G310-9. doi: 10.1152/ajpgi.00282.2013. Epub 2013 Nov 27.

  PMID: 24284963 BACKGROUND

• Vendrik KEW, Ooijevaar RE, de Jong PRC, Laman JD, van Oosten BW, van Hilten JJ, Ducarmon QR, Keller JJ, Kuijper EJ, Contarino MF. Fecal Microbiota Transplantation in Neurological Disorders. Front Cell Infect Microbiol. 2020 Mar 24;10:98. doi: 10.3389/fcimb.2020.00098. eCollection 2020.

  PMID: 32266160 BACKGROUND

• Zhou ZL, Jia XB, Sun MF, Zhu YL, Qiao CM, Zhang BP, Zhao LP, Yang Q, Cui C, Chen X, Shen YQ. Neuroprotection of Fasting Mimicking Diet on MPTP-Induced Parkinson's Disease Mice via Gut Microbiota and Metabolites. Neurotherapeutics. 2019 Jul;16(3):741-760. doi: 10.1007/s13311-019-00719-2.

  PMID: 30815845 BACKGROUND

• Huang H, Xu H, Luo Q, He J, Li M, Chen H, Tang W, Nie Y, Zhou Y. Fecal microbiota transplantation to treat Parkinson's disease with constipation: A case report. Medicine (Baltimore). 2019 Jun;98(26):e16163. doi: 10.1097/MD.0000000000016163.

  PMID: 31261545 BACKGROUND

• Bruggeman A, Vandendriessche C, Hamerlinck H, De Looze D, Tate DJ, Vuylsteke M, De Commer L, Devolder L, Raes J, Verhasselt B, Laukens D, Vandenbroucke RE, Santens P. 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. EClinicalMedicine. 2024 Mar 27;71:102563. doi: 10.1016/j.eclinm.2024.102563. eCollection 2024 May.

  PMID: 38686220 BACKGROUND

• Song YN, Yang DY, Veldhuyzen van Zanten S, Wong K, McArthur E, Song CZ, Ianiro G, Cammarota G, Kelly C, Fischer M, Russell L, Kao D. Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile Infection: Systematic Review and Meta-analysis. J Can Assoc Gastroenterol. 2021 Jul 23;5(1):e1-e11. doi: 10.1093/jcag/gwab023. eCollection 2022 Feb.

  PMID: 35118227 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Chiung-Chu Chen, PhD.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siao-Chu Su, Bachelor

CONTACT

+886978835982; b9805039@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 7, 2029
• Study Completion (Estimated): April 7, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-04