PS128 May Improve Off Duration on Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389762
• Other study ID #: PS128-02
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: June 13, 2020

Study information

• Verified date: August 2020
• 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 investigate 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: 60
• Est. completion date: June 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• daily ingestion of 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)	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 assessed on medication
Primary	Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII)	The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms.	Baseline to Week 12 assessed both off and on medications
Primary	Change in Patient "ON-OFF" diary recording	"ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states.	Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
Secondary	Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score	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.	Baseline to Week 12 assessed on Medication
Secondary	Change in Patient Global Impression of Change (PGIC)	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.	Week 12 assessed on Medication
Secondary	Change in The Parkinson's Disease Questionnaire (PDQ-39)	The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.	Baseline to Week 12 assessed on Medication