Effects of Lactobacillus Plantarum PS128 on Symptoms of Early-onset Parkinson's Disease: a Pilot Study

NCT04722198 | Unknown DMC

• 1 other identifier: PS128-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to examine L. plantarum PS128 can improve symptoms in early onset PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with early onset 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.

Conditions

Early Onset Parkinson 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 (1)

PS128

EXPERIMENTAL

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

Dietary Supplement: PS128

Interventions

PS128 DIETARY_SUPPLEMENT

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

PS128

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early Onset Parkinson's Disease, EOPD
• at least 9 years education
• age between 20 and 80 years old

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

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders

Central Study Contacts

Chin-Song Lu, MD

CONTACT

886-3-3960388; cslu.public@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 25, 2021
• Study Start: October 27, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

TW (1)