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Fecal Microbiota Transplantation in Parkinson's Disease.
Fecal Microbiota Transplantation in Parkinson's Disease.

NCT07597421

Not Yet RecruitingNA

Sponsor: Chang Gung Memorial Hospital

Conditions: Parkinson's Disease

Interventions: Fecal microbiota transplantation, Not received Fecal microbiota transplantation

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.