Fecal Microbiota Transplantation in Parkinson's Disease. (FMT)

May 13, 2026 updated by: Chang Gung Memorial Hospital

Fecal Microbiota Transplantation for the Treatment of Patients With Parkinson's Disease.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Screening and Enrollment Participants will be recruited from movement disorders clinics at Chang Gung Memorial Hospital (CGMH). Written informed consent will be obtained prior to study participation. Control group participants will undergo the same evaluation protocol as the treatment group, except for fecal microbiota transplantation (FMT).

  2. Clinical Assessments Before the baseline visit, 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.

  3. Donor Screening and Specimen Processing Healthy donors will undergo comprehensive screening, including medical history, risk assessment, and laboratory testing, in accordance with national FMT consensus guidelines. Eligible donors will provide stool samples under standardized conditions.

    Samples will be processed at the CGMH microbiota center following established protocols, including preparation for microbiome and metabolite analyses (e.g., short-chain fatty acids) using validated laboratory methods such as gas chromatography-mass spectrometry (GC-MS). Blood samples from participants will also be collected and stored for analysis.

  4. Clinical Outcome Measures

    Assessments will include:

    Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS, on/off medication) Hoehn and Yahr stage Levodopa equivalent daily dose (LEDD) Motor complications (3-day diary) Montreal Cognitive Assessment (MoCA)

    Patient-reported outcomes:

    Wearing-Off Questionnaire (WOQ-9) Parkinson's Disease Questionnaire (PDQ-39) SENS-PD (non-dopaminergic symptoms) Parkinson's Disease Constipation Questionnaire (PDCQ)

  5. FMT Procedure Participants in the treatment group will receive oral vancomycin (125 mg every 6 hours for 3 days) and follow a low-fiber diet prior to FMT. After bowel preparation and a 24-hour washout period, processed donor microbiota will be delivered to the terminal ileum or cecum via ileocolonoscopy. Participants will remain in the right lateral position for at least 30 minutes post-procedure.
  6. Specimen Storage All collected specimens will be stored at -80°C at the microbiota center until study completion. Residual samples will be transferred to the institutional biobank or destroyed according to participant consent.
  7. Transportation Microbiota preparations will be transported under controlled temperature conditions. For intra-hospital use, samples will be delivered immediately with cold-chain protection. For inter-hospital transport, samples will be frozen at -80°C, shipped on dry ice, and used on the day of arrival or stored for up to 180 days.
  8. Quality Control and Follow-up All procedures, including donor selection, sample processing, and patient care, will follow national FMT consensus guidelines. Participants will be monitored at scheduled follow-ups (1 week, 3 months, and 6 months), with additional assessments arranged as needed to ensure safety and data completeness.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hoehn-Yahr stage 5. (wheelchair ridden or bedridden due to PD)
  2. 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.
  3. Current use of probiotics or in the past 3 months.
  4. For women with childbearing potential. (Female participants are suggested to prevent pregnancy during this trial and undergo a pregnancy test before enrollment.)
  5. Current need of antibiotics or use in the previous 3 months.
  6. End stage renal disease caused uremic encephalopathy or liver cirrhosis caused hepatic encephalopathy
  7. Immunocompromised state.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group

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
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.
Active Comparator: Control Group
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
All subjects in the Control group will not receive FMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoints
Time Frame: 6 months
The change of levodopa-equivalent daily dose (LEDD) and non-motor symptoms of patients with PD after FMT.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chiung-Chu Chen, PhD., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 7, 2029

Study Completion (Estimated)

April 7, 2029

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401790A0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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