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

Kaohsiung Medical University

Status: Enrolling

Conditions: Parkinson Disease; Clostridium Butyricum Miyairi

Treatments: Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

Study type: Interventional

Funder types: Other

Identifiers

NCT06548256

KMUHIRB-F(I)-20220001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Miyarisan-BM (Clostridium Butyricum Miyairi) first

Experimental group

Description:

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

Treatment:

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

Miyarisan-BM (Clostridium Butyricum Miyairi) later

Experimental group

Description:

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

Treatment:

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)