Menu
Recruiting NCT06548256

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

No phase Interventional Clostridium Butyricum Miyairi Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Miyarisan-BM (Clostridium Butyricum Miyairi).
Who it may be relevant to
Registry conditions: Clostridium Butyricum Miyairi, Parkinson Disease. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Miyarisan-BM (Clostridium Butyricum Miyairi)
    probiotics

Primary outcome measures

  • MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 [Time frame: 0, 3, 12, 15, 24 months]
  • Hamilton Depression Rating Scale (HAM-D) [Time frame: 0, 3, 12, 15, 24 months]
  • Hamilton Anxiety Scale (HAM-A) [Time frame: 0, 3, 12, 15, 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Kaohsiung Medical Univeristy Hospital — Kaohsiung City

Identifiers

NCT: NCT06548256 · KMUHIRB-F(I)-20220001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗