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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Administration of donor FMT; Other: Administration of placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04854291

PD-FMT

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

Donor FMT

Experimental group

Description:

FMT from a healthy donor

Treatment:

Other: Administration of donor FMT

Placebo

Placebo Comparator group

Description:

NaCl + glycerol mixture (carrier solution of FMT arm)

Treatment:

Other: Administration of placebo