Status:
COMPLETED
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Turku University Hospital
Tampere University Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
35-75 years
Phase:
NA
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 m...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic PD (Clinically Probable PD)
- H\&Y OFF 1-3 at Baseline Visit
Exclusion
- Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
- Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
- Any abdominal surgery in the last 3 months
- Major genital and/or rectum prolapse
- Active autoimmune disease
- Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
- Immune deficiency
- HIV infection
- Antibiotic use in last 3 months before baseline visit
- Dementia as indicated by Moca \<21p
- Psychosis
- Active significant impulse control disorder (by interview and medical records)
- Major depression as indicated by BDI-II \>28
- Pregnancy
- Alcohol or drug abuse
- Negative dysbiosis test result
- Iodine allergy
- Deep brain stimulation or Duodopa/Lecigon treatment
- Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments
Key Trial Info
Start Date :
April 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04854291
Start Date
April 25 2021
End Date
June 13 2023
Last Update
October 10 2024
Active Locations (4)
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1
Helsinki University Central Hospital
Helsinki, Finland
2
Päijät-Häme Central Hospital
Lahti, Finland
3
Tampere University Hospital
Tampere, Finland
4
Turku University Hospital
Turku, Finland