Fecal Microbiota Transplantation for Parkinson*s Disease: a pilot study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

- Clinical diagnosis of idiopathic PD according to UK Brain Bank criteria
- PD disease duration of at least five years.
- Use of levodopa.
- Presence of motor complications (motor fluctuations or dyskinesias), despite
adequate PD medication and regardless of severity.
- Written informed consent.

Exclusion Criteria

- Hoehn and Yahr scale stage 5 (most severe stage in scale for severity of PD
motor symptoms).
- Comorbidity or condition impairing ability to participate in the study
according to the investigators.
- Current use of probiotics or in the previous three months.
- Unstable PD with change in type or dose of PD medication in the previous
three months.
- Symptoms of a GI infection during the previous three months.
- Current need of antibiotics or use in the previous three months.
- Current GI malignancy or in the previous six months.
- Known obstructions, paralysis or severe motility problems of the
gastrointestinal tract, or severe dysphagia with incapability of swallowing 2
liters of macrogol + electrolytes, or inability to receive oral feeding.
- Known diagnosis of Inflammatory Bowel Disease (IBD) or celiac disease.
- Intestinal resection in medical history.
- Recent intraabdominal surgery(< 3 months).
- Platelet count < 70x10^9/L
- Participation in another study within 16 weeks of screening visit.
- Known severe food allergy or allergy to medication that a donor could have
used (intake may lead to a life threatening situation).
- Immunocompromised state.
- Current use of immunosuppressants or opiates, or in the previous month.
- For women with child-bearing potential: Pregnancy; current wish to be
pregnant or absence of contraception; lactation.
- Impaired ability to understand the study content and to give written informed
consent.
- Unwilling or not capable to comply with the study requirements.
- Inability to communicate in Dutch.
- Inability to visit the LUMC.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoints:<br /><br>1. Feasibility of FMT in PD patients: the number of included patients that<br /><br>cannot undergo FMT due to a patient- or procedure-related reason.<br /><br>2. Safety of FMT in PD patients: FMT-related serious adverse events (SAEs)</p><br>

Secondary Outcome Measures