NCT05204641CompletedPhase 2
Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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 after FMT will be performed. The effect of FMT on frequency of constipations, which are common among Parkinson disease patients and have negative impact on quality of life and drug absorption will also be assessed. Detailed assessment of absorption of levodopa, which is the golden standard of treatment of Parkinson disease, is planned. It is planned to recruit 40 patients with diagnosis of Parkinson disease and indications for colonoscopy (constipations, age \>50 years). Patients will be randomly assigned to the group receiving treatment with FMT or identically looking placebo. It will be administered to intestine during colonoscopy. Patients will be assessed by neurologist few times after the procedure. Psychological assessment and examination of gait and balance by physiotherapist is also planned. The last assessment will be performed after 12 months to see if the clinical effect can be observed for such a long time. The composition of the intestinal microbiota will be carefully assessed before and after the procedure in order to identify pathogens that may affect the course of the disease.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 29 Nov 2021
- Start date
- 4 Jan 2022
- Primary completion date
- 8 Oct 2024
- Lead sponsor
- Medical University of Warsaw
- Diseases
- Parkinson disease
- NCT number
- NCT05204641
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 59
- From 4 Jan 2022 to the primary completion date, 8 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- radiotherapy of abdomen or pelvis region
- abdominal aortic aneurysm qualifying for surgery, pregnancy and lactation treatment with Duodopa, deep brain stimulation or apomorphine
Other illness
- perforation or obstruction of gastroenteric tract,
- severe heart, liver or kidney failure
- coagulation disorders
- immunity disorders
- current viral, bacterial or fungal infection
- severe food allergy with a history of anaphylaxis after consumption of the product.
Other
- 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)
- 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.
Who the study is looking for
- Idiopathic PD
- Consent to undergo colonoscopy
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.