Parkinson Disease
Conditions
Keywords
Parkinson's disease, FMT, microbiota, gut-brain axis
Brief summary
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.
Interventions
OTHERAdministration of donor FMT
Intracaecal infusion of FMT
Intracaecal infusion of carrier solution
Sponsors
Turku University Hospital
Tampere University Hospital
University of Helsinki
Central Hospital of Paijat-Hame
University of Aarhus
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic PD (Clinically Probable PD) * H&Y OFF 1-3 at Baseline Visit
Exclusion criteria
1. Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed) 2. Any previous major gastrointestinal surgery that may alter gastrointestinal physiology 3. Any abdominal surgery in the last 3 months 4. Major genital and/or rectum prolapse 5. Active autoimmune disease 6. Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ) 7. Immune deficiency 8. HIV infection 9. Antibiotic use in last 3 months before baseline visit 10. Dementia as indicated by Moca \<21p 11. Psychosis 12. Active significant impulse control disorder (by interview and medical records) 13. Major depression as indicated by BDI-II \>28 14. Pregnancy 15. Alcohol or drug abuse 16. Negative dysbiosis test result 17. Iodine allergy 18. Deep brain stimulation or Duodopa/Lecigon treatment 19. Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the sum of MDS-UPDRS I-III from baseline | at 6 months post intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of MDS-UPDRS IV from baseline | at 6 and 12 months post intervention | 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) |
| Change of Timed UP GO test from baseline | at 6 and 12 months post intervention | 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 |
| Change of MDS-UPDRS I from baseline | at 6 and 12 months post intervention | 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) |
| Change of NMSS from baseline | at 6 and 12 months post intervention | 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) |
| Change in gut permeability, motility and volume from baseline | at 6 months | Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans |
| Change of fecal and blood markers from baseline | whole study period | Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation |
| Change of MDS-UPDRS III from baseline | at 6 and 12 months post intervention | 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) |
| Change of BAI from baseline | at 6 and 12 months post intervention | 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) |
| Change of RBDSQ from baseline | at 6 and 12 months after intervention | REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention. |
| Change of MoCa from baseline | at 6 and 12 months post intervention | 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) |
| Change of IBS-SSS from baseline | at 6 and 12 months after intervention | The irritable bowel severity scoring system will be determined at baseline and follow-up |
| Change of PDQ39 index from baseline | at 6 and 12 months post intervention | 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) |
| Change of BDI-II from baseline | at 6 and 12 months post intervention | 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) |
Countries
Finland
Outcome results
None listed