PS128 May Improve Off Duration on Parkinson's Disease

P

Professor Lu Neurological Clinic

Status

Completed

Conditions

Parkinson Disease

Treatments

Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128

Study type

Interventional

Funder types

Other

Identifiers

NCT04389762
PS128-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

PS128
Experimental group
Description:
daily ingestion of Lactobacillus plantarum PS128 capsules
Treatment:
Dietary Supplement: daily ingestion of Lactobacillus plantarum PS128

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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