UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057204 |
|---|---|
| Receipt number | R000065387 |
| Scientific Title | Follow-up study after fecal microbiota transplantation in combination with antibiotics for patients with Parkinson's disease |
| Date of disclosure of the study information | 2025/03/04 |
| Last modified on | 2026/03/07 04:28:56 |
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Basic information
Public title
Follow-up study after fecal microbiota transplantation in combination with antibiotics for patients with Parkinson's disease
Acronym
Follow-up study after A-FMT for PD
Scientific Title
Follow-up study after fecal microbiota transplantation in combination with antibiotics for patients with Parkinson's disease
Scientific Title:Acronym
Follow-up study after A-FMT for PD
Region
| Japan |
Condition
Condition
Sporadic Parkinson's disease
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the maintenance of efficacy in patients who have completed A-FMT treatment (Fecal microbiota transplantation in combination with antibiotics)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in Movement Disorders Society Unified Parkinson's Disease Scale (MDS-UPDRS) total score from baseline (start of follow up astudy) to last assessment (32 weeks post baseline)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have participated in previous clinical study
2) Patients who have completed the A-FMT therapy of the previous clinical study (Visit 2: Week 0)
3) Patients who have received sufficient explanation and have given their written consent of their own free will after sufficiently understanding of the clinical study upon participation in this clinical study
Key exclusion criteria
1) Patients who did not completed FMT of the previous clinical study (Visit2: Week 0)
2) Other patients who are judged by the principal investigator (sub-investigator) to be inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Hatano |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
thatano@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Hatano |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
thatano@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Metagen Therapeutics, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to follow the long-term effects after the observational period of ongoing study named "A randomized, Double-blinded, placebo-controlled, parallel-group study to assess the efficacy and safety of Antibiotic fecal microbiota transplantation in patients with Parkinson's disease". Clinical scores associated with Parkinson's disease, and various biomarkers will becompared between A-FMT group and placebo group.
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065387
