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

Not Applicable

Recruiting

• Conditions: Parkinson Disease; Clostridium Butyricum Miyairi
• Interventions: Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

• Registration Number: NCT06548256
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2023-10-31
• Status Verified: 2024-01
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Miyarisan-BM (Clostridium Butyricum Miyairi) later	Miyarisan-BM (Clostridium Butyricum Miyairi)	observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year.
Miyarisan-BM (Clostridium Butyricum Miyairi) first	Miyarisan-BM (Clostridium Butyricum Miyairi)	Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAM-D)	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).
Hamilton Anxiety Scale (HAM-A)	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.
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3	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.

Trial Locations

Locations (1)

Kaohsiung Medical Univeristy Hospital; 🇨🇳 Kaohsiung city, Taiwan