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

NCT04854291 | Completed

• 1 other identifier: PD-FMT
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; FMT; microbiota; gut-brain axis

Outcome Measures

Primary Outcomes (1)

• 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)

  at 6 months post intervention

Secondary Outcomes (13)

• Change of MDS-UPDRS III from baseline

  at 6 and 12 months post intervention

• Change of MDS-UPDRS IV from baseline

  at 6 and 12 months post intervention

• Change of Timed UP GO test from baseline

  at 6 and 12 months post intervention

• Change of MDS-UPDRS I from baseline

  at 6 and 12 months post intervention

• Change of NMSS from baseline

  at 6 and 12 months post intervention

Study Arms (2)

Donor FMT

EXPERIMENTAL

FMT from a healthy donor

Other: Administration of donor FMT

Placebo

PLACEBO COMPARATOR

NaCl + glycerol mixture (carrier solution of FMT arm)

Other: Administration of placebo

Interventions

Administration of donor FMT OTHER

Intracaecal infusion of FMT

Donor FMT

Administration of placebo OTHER

Intracaecal infusion of carrier solution

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD (Clinically Probable PD)
• H\&Y OFF 1-3 at Baseline Visit

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Turku University Hospital: collaborator
• Tampere University Hospital: collaborator
• University of Helsinki: collaborator
• Central Hospital of Paijat-Hame: collaborator
• University of Aarhus: collaborator

Study Sites (4)

Helsinki University Central Hospital

Helsinki, Finland

Location

Päijät-Häme Central Hospital

Lahti, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 39073834 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Filip Scheperjans, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Neurology

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 22, 2021
• Study Start: April 25, 2021
• Primary Completion: December 27, 2022
• Study Completion: June 13, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After publication of the results for indeterminate time.
• Access Criteria: Upon reasonable request and execution of a data transfer agreement.

Locations

FI (4)