Fecal Microbiota Transplantation in Parkinson's Disease.

ConditionParkinson's Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

Fecal microbiota transplantation
Procedure/Surgery
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/Surgery
All subjects in the Control group will not receive FMT.

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Experimental GroupExperimental treatment 1 intervention

Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Secondary outcomes

Secondary endpoints

The change of levodopa-equivalent daily dose (LEDD) and non-motor symptoms of patients with PD after FMT.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: