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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD patients | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant | Combination Product | Fecal Microbiota Transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's disease symptoms | Changes in symptoms reported | 6.5 months for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in Subject microbiome from baseline | Changes in microbiome Shannon Diversity Index and relative abundance | 6.5 months for each subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Lopez | Contact | 8053390549 | alex@progenabiome.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sabine Hazan | Ventura | California | 93003 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002241 |
| Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |