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| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
| Tampere University Hospital | OTHER |
| University of Helsinki | OTHER |
| Central Hospital of Paijat-Hame |
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48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor FMT | Experimental | FMT from a healthy donor |
|
| Placebo | Placebo Comparator | NaCl + glycerol mixture (carrier solution of FMT arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of donor FMT | Other | Intracaecal infusion of FMT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the sum of MDS-UPDRS I-III from baseline | Sum of Movement Disorder Society Unified Parkinson's Disease Rating Scale sum of parts I, II, and III (in OFF state); Min 0 - Max 236 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be the primary outcome measure; Min 0 - Max 236 points (higher points indicating stronger improvement) | at 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change of MDS-UPDRS III from baseline | Movement Disorder Society Unified Parkinson's Disease Rating Scale part III (in OFF state); Min 0 - Max 132 points (higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 132 points (higher points indicating stronger improvement) | at 6 and 12 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filip Scheperjans, MD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | Finland | ||||
| Päijät-Häme Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39073834 | Result | Scheperjans F, Levo R, Bosch B, Laaperi M, Pereira PAB, Smolander OP, Aho VTE, Vetkas N, Toivio L, Kainulainen V, Fedorova TD, Lahtinen P, Ortiz R, Kaasinen V, Satokari R, Arkkila P. Fecal Microbiota Transplantation for Treatment of Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):925-938. doi: 10.1001/jamaneurol.2024.2305. |
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Raw sequencing reads will be uploaded to the European Nucleotide Archive. Upon reasonable request and execution of a data transfer agreement we will share de-identified clinical data and metadata in the range that is permitted by local legislation.
After publication of the results for indeterminate time.
Upon reasonable request and execution of a data transfer agreement.
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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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| UNKNOWN |
| University of Aarhus | OTHER |
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| Administration of placebo |
| Other |
Intracaecal infusion of carrier solution |
|
| Change of MDS-UPDRS IV from baseline | Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV; Min 0 - Max 132 points (higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 24 points (higher points indicating stronger improvement) | at 6 and 12 months post intervention |
| Change of Timed UP GO test from baseline | measured in seconds, higher value indicating worse clinical symptoms expressed as difference between 6 and 12 month post intervention and baseline, higher value indicating stronger improvement | at 6 and 12 months post intervention |
| Change of MDS-UPDRS I from baseline | Movement Disorder Society Unified Parkinson's Disease Rating Scale part I; Min 0 - Max 52 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be calculated; Min 0 - Max 52 points (higher points indicating stronger improvement) | at 6 and 12 months post intervention |
| Change of NMSS from baseline | Non-motor symptom scale (0-360 points, higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 360 points (higher points indicating stronger improvement) | at 6 and 12 months post intervention |
| Change in gut permeability, motility and volume from baseline | Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans | at 6 months |
| Change of fecal and blood markers from baseline | Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation | whole study period |
| Change of BDI-II from baseline | Beck Depression Inventory II (0-63 points, higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 63 points (larger decrease indicating stronger improvement) | at 6 and 12 months post intervention |
| Change of BAI from baseline | Beck Anxiety inventory will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 63 points (larger decrease indicating stronger improvement) | at 6 and 12 months post intervention |
| Change of RBDSQ from baseline | REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention. | at 6 and 12 months after intervention |
| Change of MoCa from baseline | MONTREAL COGNITIVE ASSESSMENT (0-30 points, higher points indicating less symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 30 points (higher increase indicating stronger improvement) | at 6 and 12 months post intervention |
| Change of IBS-SSS from baseline | The irritable bowel severity scoring system will be determined at baseline and follow-up | at 6 and 12 months after intervention |
| Change of PDQ39 index from baseline | Parkinson's Disease Questionnaire 39 index (0-100 points, higher points indicating worse quality of life) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 100 points (larger decrease indicating stronger improvement) | at 6 and 12 months post intervention |
| Lahti |
| Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |