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

NCT06548256 | Recruiting DMC

• 1 other identifier: KMUHIRB-F(I)-20220001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Clostridium Butyricum Miyairi; Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3

  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)

  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)

  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

Study Arms (2)

Miyarisan-BM (Clostridium Butyricum Miyairi) first

EXPERIMENTAL

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

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

Miyarisan-BM (Clostridium Butyricum Miyairi) later

EXPERIMENTAL

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

Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)

Interventions

Miyarisan-BM (Clostridium Butyricum Miyairi) DRUG

probiotics

Miyarisan-BM (Clostridium Butyricum Miyairi) first; Miyarisan-BM (Clostridium Butyricum Miyairi) later

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• People with Parkinson's disease Dementia, or Lactose Intolerance

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical Univeristy Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

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

CONTACT

886-7-2911101; cyp905@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: August 12, 2024
• Study Start: October 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)