Clinical trial NCT04854291: A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
Official title: A Randomized, Double Blind, Placebo Controlled Multicenter Trial of Fecal Microbiome Transplantation Safety and Efficacy for Parkinson's Disease Patients with Abnormal Gut Microbiota Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
FMT
microbiota
gut-brain axis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Tampere University Hospital
name: University of Helsinki
name: Central Hospital of Paijat-Hame
name: University of Aarhus
First posted: 2021-04-22
Enrollment: 51
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of the sum of MDS-UPDRS I-III from baseline
timeFrame: at 6 months post intervention
Secondary outcomes:
measure: Change of MDS-UPDRS III from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of MDS-UPDRS IV from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of Timed UP GO test from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of MDS-UPDRS I from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of NMSS from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change in gut permeability, motility and volume from baseline
timeFrame: at 6 months
measure: Change of fecal and blood markers from baseline
timeFrame: whole study period
measure: Change of BDI-II from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of BAI from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of RBDSQ from baseline
timeFrame: at 6 and 12 months after intervention
measure: Change of MoCa from baseline
timeFrame: at 6 and 12 months post intervention
measure: Change of IBS-SSS from baseline
timeFrame: at 6 and 12 months after intervention
measure: Change of PDQ39 index from baseline
timeFrame: at 6 and 12 months post intervention
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Filip Scheperjans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheperjans F, Levo R, Bosch B, Laaperi M, Pereira PAB, Smolander OP, Aho VTE, Vetkas N, Toivio L, Kainulainen V, Fedorova TD, Lahtinen P, Ortiz R, Kaasinen V, Satokari R, Arkkila P. Fecal Microbiota Transplantation for Treatment of Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):925-938. doi: 10.1001/jamaneurol.2024.2305.