Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647277
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Fecal MicrobiotaTransplant for the Treatment of Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Phase I Clinical Trial of Vancomycin Followed by Fecal Microbiota Transplant for the Treatment of Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None