PS128 May Improve Off Duration on Parkinson's Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2020-06-13

Brief Summary

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The purpose of this study is to investigate the short term effects (12 Weeks) of Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.

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Detailed Description

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This study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 treatment for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PS128

daily ingestion of Lactobacillus plantarum PS128 capsules

Group Type EXPERIMENTAL

daily ingestion of Lactobacillus plantarum PS128

Intervention Type DIETARY_SUPPLEMENT

daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)

Interventions

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daily ingestion of Lactobacillus plantarum PS128

daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with idiopathic Parkinson's Disease
* According to the record of ON / OFF diary for 3 consecutive days, the patient's daily off periods must be more than 3 hours a day.
* Between ages of 40-80 years old.

Exclusion Criteria

* Patients on antibiotics within the preceding one month
* Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
* Have undergone surgery of liver, bladder, or gastrointestinal tract
* Have current or history of inflammatory bowel disease
* Have history of cancer
* Known allergy to probiotics
* Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
* Have received deep brain stimulation
* Patients receiving artificial enteral or intravenous nutrition

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No