Parkinson Disease
Conditions
Brief summary
FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.
Detailed description
This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease. Subjects in the study are required to meet with the study clinician on 11 occasions: two (2) visits for informed consent and baseline assessment, one (1) visit prior to FMT for colonoscopy instructions and exam, one (1) visit for the fecal microbiota transplant procedure by colonoscopy at an outpatient surgical center, seven (7) visits for post-FMT assessment. There are also daily phone calls in the week following the FMT, and weekly phone call visits (during weeks in which there is not a physical visit) to check up on how the subject is doing, any change in medications, side effects, and answer any questions.
Interventions
COMBINATION_PRODUCTFecal Microbiota Transplant
Fecal Microbiota Transplant
Sponsors
ProgenaBiome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with PD
Exclusion criteria
* Non-PD individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's disease symptoms | 6.5 months for each subject | Changes in symptoms reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alterations in Subject microbiome from baseline | 6.5 months for each subject | Changes in microbiome Shannon Diversity Index and relative abundance |
Countries
United States
Contacts
Primary ContactAlex Lopez
Outcome results
None listed