The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease

NCT ID: NCT06548256

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2026-12-31

Brief Summary

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This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease

Detailed Description

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The physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. And randomly divided into experimental and observation groups, and according to the timing of taking Miyarisan, scale evaluation and sample collection.

Conditions

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Clostridium Butyricum Miyairi Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year Drug: observed for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Miyarisan-BM (Clostridium Butyricum Miyairi) first

Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year

Group Type EXPERIMENTAL

Miyarisan-BM (Clostridium Butyricum Miyairi)

Intervention Type DRUG

probiotics

Miyarisan-BM (Clostridium Butyricum Miyairi) later

observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year.

Group Type EXPERIMENTAL

Miyarisan-BM (Clostridium Butyricum Miyairi)

Intervention Type DRUG

probiotics

Interventions

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Miyarisan-BM (Clostridium Butyricum Miyairi)

probiotics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female over 20 years old, diagnosed with Parkinson's disease.

Exclusion Criteria

* People with Parkinson's disease Dementia, or Lactose Intolerance
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Medical Univeristy Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yang-Pei Chang, M.D.; MSc.

Role: CONTACT

886-7-2911101 ext. 8913

Facility Contacts

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Yang-Pei Chang, M.D.; MSc,

Role: primary

886-7-2911101 ext. 8913

Other Identifiers

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KMUHIRB-F(I)-20220001

Identifier Type: -

Identifier Source: org_study_id

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