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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: placebo; Dietary Supplement: PS128

• Registration Number: NCT04722211
• Lead Sponsor: Professor Lu Neurological Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-06
• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-25
• Last Update Posted: 2021-01-25
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose
PS128	PS128	Each PS128 capsule contained \>1 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg

Primary Outcome Measures

Name	Time	Method
TUG	12 weeks	Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
UPDRS III	12 weeks	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.
MHY	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
UPDRS I-IV	Baseline and Post-12 weeks	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.
SCL-90-R	Baseline and Post-12 weeks	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.
VAS-GI	Baseline and Post-12 weeks	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).
CPSQI	Baseline and Post-12 weeks	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.
PGIC	Post-12 weeks	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."

Trial Locations

Locations (1)

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