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NCT Number: NCT06548256

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

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

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Key information

Conditions

Clostridium Butyricum Miyairi Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical Univeristy Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

886-7-2911101 ext. 8913

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Miyarisan-BM (Clostridium Butyricum Miyairi)

Drug

probiotics

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

886-7-2911101 ext. 8913

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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