Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.

Parkinson Disease Clinical Trial

Official title:

Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722211
• Other study ID #: PS128-03
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: June 30, 2023

Study information

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

Clinical Trial Summary

This RCT 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 or placebo intervention for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Description:

This RCT 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 or placebo intervention 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: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Modified Hoehn &Yahr stage, MHY 1-3

• 45-80 years old

• at least 9 years education

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

• Diagnosed before 40 years old

• Poor control of other chronic diseases

• Not eligible judged by PI

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders

Intervention

Dietary Supplement:
• PS128
daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)
• placebo
daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose

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	UPDRS III	The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.; The PART III is Motor sections.	12 weeks
Primary	MHY	The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.; The modified Hoehn and Yahr scale included stages 1 through 5. to help describe the intermediate course of the disease.	12 weeks
Primary	TUG	Observe the patient's postural stability, gait, stride length, sway and test cut-off times.	12 weeks
Secondary	UPDRS I-IV	The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.; The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.	Baseline and Post-12 weeks
Secondary	SCL-90-R	The Symptom Checklist-90-Revised instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology.; The SCL-90-R is normed on individuals 13 years and older. It consists of 90 items and takes 12-15 minutes to administer.	Baseline and Post-12 weeks
Secondary	CPSQI	The Chinese Version of the Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality.	Baseline and Post-12 weeks
Secondary	VAS-GI	Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).	Baseline and Post-12 weeks
Secondary	PGIC	The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."	Post-12 weeks