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| Name | Class |
|---|---|
| Human Biome Institute S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal microbiota transplant | Active Comparator | Pretreatment with rifaximin 3x 400 mg PO for 5 days Fecal Microbiota Transfer from healthy donor during colonoscopy. Assessments in clinical scales: 30 days, 90 days, 180 days and 12 months: Unified Parkinson Disease Rating Scale, modified Constipation Assessment Scale, Parkinson Disease Questionnaire-39, Non- Motor Symptoms Questionnaire, Gastrointestinal Dysfunction Scale for Parkinson Disease. Assessment of levodopa/benserazide 200+50 mg tablet pharmacokinetics before and 30 days and 1 year after intervention |
|
| Autotransplant of patients microbiota | Placebo Comparator | Pretreatment with rifaximin 3x 400 mg PO for 5 days Administration of auto-FMT during colonoscopy Assessments in clinical scales: 30 days, 90 days, 180 days and 12 months: Unified Parkinson Disease Rating Scale, modified Constipation Assessment Scale, Parkinson Disease Questionnaire-39, Non- Motor Symptoms Questionnaire, Gastrointestinal Dysfunction Scale for Parkinson Disease. Assessment of levodopa/benserazide 200+50 mg tablet pharmacokinetics before and 30 days and 1 year after intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transfer provided by Human Biome Institute | Biological | Fecal Microbiota Transfer with colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in progression of motor symptoms of Parkinson Diseae | Reduction or no change in Unified Parkinson Disease Rating Scale part III (motor) in off state (min. 0, max 108 points) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bowel movements | Change of score in Gastrointestinal Dysfunction Scale for Parkinson Disease ( a minimum score of 1 and a maximum score of 108) | 0,1,3,6,12 months |
| Change in bowel movements |
| Measure | Description | Time Frame |
|---|---|---|
| Change of levodopa bioavailability | Change in levodopa-carbidopa concentration in peripheral blood (AUC) | 1 months, 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Faculty of health sciences, Medical University of Warsaw | Warsaw | 03-242 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41674471 | Derived | Figura M, Milanowski L, Nowak JM, Antoniak A, Kopczynski M, Zajac W, Sadowski K, Holubiuk L, Walecik-Kot W, Szlufik S, Friedman A, Kaczmarczyk B, Bilinski J, Koziorowski D. Safety and Efficacy of Fecal Microbiota Transplantation in Alleviating Symptoms of Parkinson's Disease: A Randomized, Placebo-Controlled, Double-Blinded Study. Ann Neurol. 2026 Jul;100(1):10-21. doi: 10.1002/ana.78153. Epub 2026 Feb 12. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
Change of score in modified Constipation Assessment Scale (a minimum score of 0 and a maximum score of 16)
| 0,1,3,6,12 months |
| Change in MDS- Non Motor Scale and subscales | Rater-completed assessment that measures frequency and severity of 13 non-motor domains, over 52 items and covers a range of key non-motor symptoms both PD and treatment related | 0,1,3,6,12 months |
| MoCA change | Detection of dementia symptoms. It is a 30-point assessment that takes about 10 minutes to complete with a physician. | It is a 30-point assessment that takes about 10 minutes to complete |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |