Effects of PS128 on Parkinsonian Symptoms

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566589
• Other study ID #: PS128-01
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2021
• Source: Professor Lu Neurological Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders

Intervention

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

Locations

Country	Name	City	State
Taiwan	Professor Lu Neurological Clinic	Taoyuan City	Guishan Dist.

Sponsors (1)

Lead Sponsor	Collaborator
Professor Lu Neurological Clinic

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Week 12
Secondary	Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From Baseline 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.	to Week 12 Assessed On Medication
Secondary	Change in Patient Global Impression of Change (PGIC) Score From Baseline 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.	to Week 12 Assessed On Medication