Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.

NCT ID: NCT04722211

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2023-06-30

Brief Summary

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This RCT 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 or placebo intervention 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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This RCT 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 or placebo intervention 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

RANDOMIZED

Intervention Model

PARALLEL

120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

placebo

The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose

Interventions

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PS128

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

Intervention Type DIETARY_SUPPLEMENT

placebo

daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Modified Hoehn \&Yahr stage, MHY 1-3
* 45-80 years old
* at least 9 years education

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

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Facility Contacts

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CHIN-SONG LU, MD

Role: primary

033960388

Other Identifiers

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PS128-03

Identifier Type: -

Identifier Source: org_study_id

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