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

NCT04722211 | Unknown

• 1 other identifier: PS128-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

probiotics, parkinson's disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• TUG

  Observe the patient's postural stability, gait, stride length, sway and test cut-off times.

  12 weeks

Secondary Outcomes (5)

• UPDRS I-IV

  Baseline and Post-12 weeks

• SCL-90-R

  Baseline and Post-12 weeks

• CPSQI

  Baseline and Post-12 weeks

• VAS-GI

  Baseline and Post-12 weeks

• PGIC

  Post-12 weeks

Study Arms (2)

PS128

EXPERIMENTAL

Each PS128 capsule contained \>1 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg

Dietary Supplement: PS128

placebo

PLACEBO COMPARATOR

The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose

Dietary Supplement: placebo

Interventions

PS128 DIETARY_SUPPLEMENT

daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (\>10 billion CFU/capsule)

PS128

placebo DIETARY_SUPPLEMENT

daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose

placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Modified Hoehn \&Yahr stage, MHY 1-3
• years old
• at least 9 years education

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Lu Neurological Clinic: lead

Study Sites (1)

Professor Lu Neurological Clinic

Taoyuan, Guishan Dist., 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 25, 2021
• Study Start: July 6, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

TW (1)