A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
- Conditions
- Parkinson Disease
- Registration Number
- NCT04854291
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Diagnosis of idiopathic PD (Clinically Probable PD)<br><br> - H&Y OFF 1-3 at Baseline Visit<br><br>Exclusion Criteria:<br><br> 1. Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten<br> free diet, gastritis allowed)<br><br> 2. Any previous major gastrointestinal surgery that may alter gastrointestinal<br> physiology<br><br> 3. Any abdominal surgery in the last 3 months<br><br> 4. Major genital and/or rectum prolapse<br><br> 5. Active autoimmune disease<br><br> 6. Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma<br> in situ)<br><br> 7. Immune deficiency<br><br> 8. HIV infection<br><br> 9. Antibiotic use in last 3 months before baseline visit<br><br> 10. Dementia as indicated by Moca <21p<br><br> 11. Psychosis<br><br> 12. Active significant impulse control disorder (by interview and medical records)<br><br> 13. Major depression as indicated by BDI-II >28<br><br> 14. Pregnancy<br><br> 15. Alcohol or drug abuse<br><br> 16. Negative dysbiosis test result<br><br> 17. Iodine allergy<br><br> 18. Deep brain stimulation or Duodopa/Lecigon treatment<br><br> 19. Inability to interrupt regular use of NSAIDs for at least one month before<br> permeability assessments
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of the sum of MDS-UPDRS I-III from baseline
- Secondary Outcome Measures
Name Time Method Change of MDS-UPDRS III from baseline;Change of MDS-UPDRS IV from baseline;Change of Timed UP GO test from baseline;Change of MDS-UPDRS I from baseline;Change of NMSS from baseline;Change in gut permeability, motility and volume from baseline;Change of fecal and blood markers from baseline;Change of BDI-II from baseline;Change of BAI from baseline;Change of RBDSQ from baseline;Change of MoCa from baseline;Change of IBS-SSS from baseline;Change of PDQ39 index from baseline