A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

Helsinki University Central Hospital51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease

Interventions

Administration of donor FMTOTHER

Intracaecal infusion of FMT

Administration of placeboOTHER

Intracaecal infusion of carrier solution

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

Helsinki University Central Hospital

Helsinki, Finland

Päijät-Häme Central Hospital

Lahti, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

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)

Time frame: at 6 months post intervention

Secondary Outcomes

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)

Time frame: at 6 and 12 months post intervention

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)

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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