A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of Antibiotic Fecal Microbiota Transplantation (A-FMT) in patients with Parkinson's disease

JRCT ID: jRCTs031240344

Registered date:18/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced stage sporadic Parkinson's disease
• Date of first enrollment: 18/09/2024
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Three antimicrobial agents are administered for 5 days. 2 - 7 days after administration of antimicrobial agents, patients are randomly assigned to the test drug treatment group or the placebo group and each will received one dose of FMT or a placebo solution.

Outcome(s)

• Primary Outcome: The amount of change in Movement Disorders Society Unified Parkinson's Disease Scale (MDS-UPDRS) total score from baseline (start of antimicrobial therapy) to last assessment (8 weeks post FMT)

Secondary Outcome

1) MDS-UPDRS total score (change from baseline to 4 weeks FMT after completion of antimicrobial therapy)
2) MDS-UPDRS part I, II, III, IV (change from baseline to 4 weeks FMT and 8 weeks FMT after completion of antimicrobial therapy)
3) Objective assessment of diurnal variation in motor symptoms (change from baseline to 8 weeks post-antimicrobial withdrawal and 8 weeks post-FMT)
4) Various self-administered endpoints (PDQ39, BDI-II, WOQ19, SCOPA-AUT, PDSS-2) (change from baseline to end of antimicrobial regimen, 4 weeks after FMT, and 8 weeks after FMT)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients who are at least 40 years old to 75 years old or less at the time of obtaining consent ( at the time of obtaining consent )
2) Patients with a sporadic Parkinson's disease ( Clinically established PD with MDS clinical diagnostic criteria) ( at the time of obtaining consent )
3) Patients with clear diurnal variation in motor symptoms ( at the time of obtaining consent )
4) Patients who can obtain written consent of their own free will ( at the time of obtaining consent )
5) Patients with H&Y of 3 or less at the time of On ( at the time of obtaining consent , primary registration)
6) Patients who are outpatients ( at the time of obtaining consent )
7) Patients without psychiatric symptoms or cognitive impairment ( at the time of obtaining consent , primary enrollment)
8) Patients who are judged by the principal investigator (sub-investigator) to be adequately evaluated for the efficacy and safety of the study after considering the inclusion and exclusion criteria ( at the time of obtaining consent , primary enrollment, secondary enrollment*)
*In the case of secondary enrollment, Patients who are judged by the principal investigator (sub-investigator) to be eligible for appropriate evaluation of the efficacy and safety of this study (including confirmation of antimicrobial compliance)

Exclude criteria

1) Patients with serious gastrointestinal diseases other than constipation and patients with a history of colorectal resection ( at the time of obtaining consent )
2) Patients with Helicobacter pylori infection (primary enrollment)
3) Patients with serious cardiac disease, renal disease (serum creatinine >= 2.0 mg/dL or BUN >= 25 mg/dL), or hepatic disease (total bilirubin >= 3.0 mg/dL or AST (GOT) or ALT (GPT) >= 100 IU/L) (primary enrollment)
4) Patients suffering from autoimmune or infectious diseases ( at the time of obtaining consent )
5) Patients with immunodeficiency ( at the time of obtaining consent , primary enrollment)
6) Patients with malignant tumors or who have not passed 5 years since treatment ( at the time of obtaining consent )
7) Patients with concomitant drug hypersensitivity or history of drug hypersensitivity to laxatives and antimicrobial agents used in this study ( at the time of obtaining consent , primary enrollment)
8) Patients with a history of antimicrobial use within 3 months of primary enrollment (primary enrollment)
9) Patients with a history of entacapone use within 4 weeks of the primary enrollment date (primary enrollment)
10) Patients with a history of use of intestinal regulators within 1 week of primary enrollment (primary enrollment)
11)Patients with a history of live vaccination within 4 weeks of primary enrollment (primary enrollment)
12) Pregnant or possibly pregnant women, men and women who cannot consent to contraception during study participation ( at the time of obtaining consent, primary enrollment, secondary enrollment )
13) Women who are breastfeeding ( at the time of obtaining consent )
14)Patients who have received any other investigational drug within 12 weeks prior to the examination, observation, etc. specified in this study protocol ( primary enrollment)
15) Other patients who are judged by the principal investigator (sub-investigator) to be inappropriate as subjects ( at the time of obtaining consent, primary enrollment, secondary enrollment*)
*In the case of secondary enrollment, Patients whom the principal investigator (sub-investigator) judges that the efficacy and safety of the study can be appropriately evaluated (including confirmation of antimicrobial compliance).

Related Information

• Primary Sponsor: Hatano Taku
• Source(s) of Monetary Support: Metagen Therapeutics, Inc.