Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
fecal microbial transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.
- Subjects complaining of constipation .
- Subjects who did not perform a screening colonoscopy for colon cancer.
- Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.
Exclusion Criteria:
- Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.
- Subjects who already underwent a screening colonoscopy for colon cancer.
- Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.
Sites / Locations
- Soroka Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
PD patients that will receive FMT
PD patients that will not receive FMT
healthy people live with PD patients
Arm Description
fecal microbial transplantation once at the beginning of the study-15 patients.
do not receive treatment-35 patients.
do not receive treatment-50 participants.
Outcomes
Primary Outcome Measures
motor parkinsonian symptoms
motor symptoms assessed by UPDRS III questionaire
constipation level
constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).
Secondary Outcome Measures
Full Information
NCT ID
NCT03876327
First Posted
February 20, 2019
Last Updated
August 2, 2020
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03876327
Brief Title
Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease
Official Title
Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 19, 2015 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD.
Detailed Description
Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients and may precede the onset of motor symptoms by years.
this study include one group of PD patients that will receive FMT. two other groups will serve as controls:
PD patients that will not receive FMT
healthy people who live with PD patients in the same house and share similar surrounding
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
3 groups were included in the study:
PD patients that will undergo FMT tretment and a half of year follow-up-15 patients.
PD patients that will not undergo FMT procedure and will donate stool sample only once-35 patients.
healthy PD relatives, that live with them and have similiar life styling and which will donate stool sample only once-50 participants.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD patients that will receive FMT
Arm Type
Experimental
Arm Description
fecal microbial transplantation once at the beginning of the study-15 patients.
Arm Title
PD patients that will not receive FMT
Arm Type
No Intervention
Arm Description
do not receive treatment-35 patients.
Arm Title
healthy people live with PD patients
Arm Type
No Intervention
Arm Description
do not receive treatment-50 participants.
Intervention Type
Procedure
Intervention Name(s)
fecal microbial transplantation
Intervention Description
Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
Primary Outcome Measure Information:
Title
motor parkinsonian symptoms
Description
motor symptoms assessed by UPDRS III questionaire
Time Frame
Change from baseline motor difficulties at 6 months
Title
constipation level
Description
constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).
Time Frame
Change from baseline constipation level at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.
Subjects complaining of constipation .
Subjects who did not perform a screening colonoscopy for colon cancer.
Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.
Exclusion Criteria:
Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.
Subjects who already underwent a screening colonoscopy for colon cancer.
Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arik segal, MD
Organizational Affiliation
SOROKA MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Be'er Sheva
ZIP/Postal Code
151
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34237681
Citation
Segal A, Zlotnik Y, Moyal-Atias K, Abuhasira R, Ifergane G. Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series. Clin Neurol Neurosurg. 2021 Aug;207:106791. doi: 10.1016/j.clineuro.2021.106791. Epub 2021 Jun 30.
Results Reference
derived
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Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease
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