Status:
COMPLETED
Fecal Microbiota Transplantation for Parkinson's Disease
Lead Sponsor:
University Ghent
Collaborating Sponsors:
University Hospital, Ghent
the Flanders Institute for Biotechnology
Conditions:
Parkinson Disease
Eligibility:
All Genders
50-65 years
Phase:
NA
Brief Summary
Parkinson's disease (PD) is the second most common neurodegenerative disorder and due to the lack of early diagnosis and effective therapy, represents a large burden for our society and healthcare sys...
Detailed Description
In this study the effects of fecal microbiota transplantation (FMT) on patients with Parkinson's disease will be investigated in a double-blind, placebo-controlled randomized clinical trial. At time ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients:
- Signed informed consent.
- Clinical PD diagnosis (MDS criteria)
- Hoehn \& Yahr score of 2-3 in OFF
- Age of motor symptoms onset \> 50 years
- Exclusion Criteria for patients:
- First degree relative or more than one relative with PD
- Diagnosis of dementia or MMSE \< 25
- Diagnosis of major depression or psychosis (DSM-V criteria)
- Any of the following within the previous 2 months: hospital admission, narcosis or sedation, abdominal trauma
- Primary disease of gastrointestinal tract (exception: chronic gastritis)
- Previous abdominal or anorectal surgery (causing structural abnormalities of the intestines)
- Any of the following within the previous 2 months: gastrointestinal or respiratory tract infection, food intoxication
- The use of probiotics or antibiotics within three months prior to FMT
- Contra-indications for colonoscopy
- Other immune disorder or clinical immunosuppression
- Drug abuse
- Malignancy
- Any severe comorbidity that might interfere with the study course as determined by the treating physician
- Pregnancy or inadequate anti conception for the duration of the trial
- Inclusion criteria for donors
- age 18 - 75 years
- signed informed consent
- normal screening protocol, including screening for infectious diseases, according to the recommendations of the Superior Health Council of Belgium concerning the safety and quality of fecal transplantation in humans
- Exclusion criteria for donors
- presence of gastrointestinal symptoms
- gastro-intestinal or other important comorbidity
- obesity or metabolic syndrome
- history of malignancy both gastrointestinal or systemic
- presence of known colon polyps
- recent placing of piercings/tattoos
- sexual risk behaviour
- antimicrobial therapy 3 months prior to donation
- living in the same household as a Parkinson's disease patient
Exclusion
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03808389
Start Date
December 1 2020
End Date
December 9 2022
Last Update
January 30 2023
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000