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

August 8, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yang-Pei Chang, M.D.; MSc.
  • Phone Number: 8913 886-7-2911101
  • Email: cyp905@gmail.com

Study Locations

  • Taiwan
      • Kaohsiung city, Taiwan
        • Recruiting
        • Kaohsiung Medical Univeristy Hospital
        • Contact:
          • Yang-Pei Chang, M.D.; MSc,
          • Phone Number: 8913 886-7-2911101
          • Email: cyp905@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miyarisan-BM (Clostridium Butyricum Miyairi) first
Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year
Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)
probiotics
Experimental: Miyarisan-BM (Clostridium Butyricum Miyairi) later
observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year.
Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)
probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Time Frame: 0, 3, 12, 15, 24 months
Part 3 of this scale assesses motor performance in 33 items. Each item is scored on a scale of 0 (normal) to 4 (severe), with a total score range of 0 to 132, and higher scores mean the patient's situation is worse.
0, 3, 12, 15, 24 months
Hamilton Depression Rating Scale (HAM-D)
Time Frame: 0, 3, 12, 15, 24 months
This scale assesses non-motor symptoms in 17 items, the total scale value is 50 (Scores 0 to 7 mean normal, 8 to 13 mean mild depression, 14 to 18 mean moderate depression, 19 to 22 mean severe depression, and ≥23 mean very severe depression).
0, 3, 12, 15, 24 months
Hamilton Anxiety Scale (HAM-A)
Time Frame: 0, 3, 12, 15, 24 months
This scale assesses non-motor symptoms in 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where ≤17 indicates mild anxiety severity, 18-24 indicate mild to moderate anxiety severity, 25-30 indicate moderate to severe anxiety severity, >30 indicate severe anxiety.
0, 3, 12, 15, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(I)-20220001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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