Skip to main content
OpenTrials
Completed

NCT Number: NCT03566589

Effects of PS128 on Parkinsonian Symptoms

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professor Lu Neurological Clinic

Taoyuan City, Guishan Dist., 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages of 40-80 years old
  • Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 2.5 as rated during an "on" period

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 current or history of inflammatory bowel disease
  • Have history of cancer
  • Have undergone surgery of liver, bladder, or gastrointestinal tract
  • 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

Treatment and study plan

Lactobacillus plantarum PS128

Dietary Supplement

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

Other names: PS128

Primary outcomes

  1. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 12 Assessed On Medication

    Time frame: Baseline to Week 12

    The UPDRS scores is a rating tool used to gauge the course of Parkinson's disease in patients. The minimum total score possible is 0 and the maximum total score possible is 199. Higher values represent a worse outcome.

Secondary outcomes

  1. Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From Baseline to Week 12 Assessed On Medication

    Time frame: to Week 12 Assessed On Medication

    NMS-Quest is a 30-item Screening tool for non-motor symptoms of Parkinson's disease. The minimum total score possible is 0 and the maximum total score possible is 30. Higher values represent a worse outcome.

  2. Change in Patient Global Impression of Change (PGIC) Score From Baseline to Week 12 Assessed On Medication

    Time frame: to Week 12 Assessed On Medication

    The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.

Sponsors and collaborators

Lead sponsor

Professor Lu Neurological Clinic

Other

Registry information

Official study title

Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2018
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.