Status:
COMPLETED
Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Human Biome Institute S.A.
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The aim of the study is to assess impact of Fecal Microbiota Transfer (FMT) on clinical symptoms of Parkinson's disease. Assesment of tremor, slowness of movements and balance problems before and afte...
Eligibility Criteria
Inclusion
- Idiopathic PD
- Consent to undergo colonoscopy
Exclusion
- perforation or obstruction of gastroenteric tract,
- radiotherapy of abdomen or pelvis region
- severe heart, liver or kidney failure
- coagulation disorders
- immunity disorders
- current viral, bacterial or fungal infection
- abdominal aortic aneurysm qualifying for surgery, pregnancy and lactation treatment with Duodopa, deep brain stimulation or apomorphine
- colonoscopy confirmed colon polyps, except for lesions \<5 mm qualified for the NBI International Colorectal Endoscopic I group or other potentially neoplastic lesions after evaluation in white light and narrow beam imaging (NBI)
- severe food allergy with a history of anaphylaxis after consumption of the product.
- microbiological stool evaluation with detection of: methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella pneumoniae carbapenemase (KPC), metallo-β-lactamase (MBL), extended-spectrum beta-lactamase (ESBL), vancomycin-resistant Enterococci (VRE), Salmonella, Shigella, Yersinia. If any other atypical pathogen are to be detected in general stool culture, it will be assessed on an individual basis.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05204641
Start Date
January 4 2022
End Date
October 8 2024
Last Update
April 27 2025
Active Locations (1)
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1
Department of Neurology, Faculty of health sciences, Medical University of Warsaw
Warsaw, Poland, 03-242