Effects of Lactobacillus Plantarum PS128 on Symptoms of Early-onset Parkinson's Disease: a Pilot Study

NCT ID: NCT04722198

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2021-12-31

Brief Summary

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This study is designed to examine L. plantarum PS128 can improve symptoms in early onset PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with early onset 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.

Detailed Description

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Conditions

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Early Onset Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PS128

Each PS128 capsule contained \>1 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg

Group Type EXPERIMENTAL

PS128

Intervention Type DIETARY_SUPPLEMENT

daily ingestion 2 capsules of Lactobacillus plantarum PS128 (\>10 billion CFU/capsule)

Interventions

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PS128

daily ingestion 2 capsules of Lactobacillus plantarum PS128 (\>10 billion CFU/capsule)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Early Onset Parkinson's Disease, EOPD
* at least 9 years education
* age between 20 and 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
* Diagnosed before 40 years old
* Poor control of other chronic diseases
* Not eligible judged by PI
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Lu Neurological Clinic

OTHER

Sponsor Role lead

Responsible Party

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CHIN-SONG LU

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Professor Lu Neurological Clinic

Taoyuan, Guishan Dist., Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Song Lu, MD

Role: CONTACT

886-3-3960388

Facility Contacts

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CHIN-SONG LU, MD

Role: primary

033960388

Other Identifiers

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PS128-04

Identifier Type: -

Identifier Source: org_study_id

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