Fecal Microbiota Transplantation in Parkinson's Disease.

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT07597421
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Not received Fecal microbiota transplantation — PROCEDURE
    All subjects in the Control group will not receive FMT.

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Apr 7, 2029
Completion
Apr 7, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Primary endpoint [ Time Frame: 6 months ]

Central Contacts

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