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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

People with Parkinson's disease Dementia, or Lactose Intolerance

Trial design

Design model

Single group

Treatments tested in this trial

  • Miyarisan-BM (Clostridium Butyricum Miyairi)

    Drug

    probiotics

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Miyarisan-BM (Clostridium Butyricum Miyairi) firstExperimental treatment 1 intervention
Group B: Miyarisan-BM (Clostridium Butyricum Miyairi) laterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
0, 3, 12, 15, 24 months
2

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).

Time frame
0, 3, 12, 15, 24 months
3

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.

Time frame
0, 3, 12, 15, 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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