Effects of PS128 on Parkinsonian Symptoms

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: Lactobacillus plantarum PS128

• Registration Number: NCT03566589
• Lead Sponsor: Professor Lu Neurological Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-25
• Study Start: 2018-07-02
• Primary Completion: 2018-11-09
• Study Completion: 2018-12-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PS128	Lactobacillus plantarum PS128	daily ingestion of Lactobacillus plantarum PS128 capsules

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From Baseline to Week 12 Assessed On Medication	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.
Change in Patient Global Impression of Change (PGIC) Score From Baseline to Week 12 Assessed On Medication	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.

Trial Locations

Locations (1)

Professor Lu Neurological Clinic; 🇨🇳 Taoyuan City, Guishan Dist., Taiwan