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

P

Professor Lu Neurological Clinic

Status

Unknown

Conditions

Early Onset Parkinson Disease

Treatments

Dietary Supplement: PS128

Study type

Interventional

Funder types

Other

Identifiers

NCT04722198
PS128-04

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Early Onset Parkinson's Disease, EOPD
  • at least 9 years education
  • age between 20 and 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
  • Diagnosed before 40 years old
  • Poor control of other chronic diseases
  • Not eligible judged by PI

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

PS128
Experimental group
Description:
Each PS128 capsule contained \>1 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg
Treatment:
Dietary Supplement: PS128

Trial contacts and locations

1

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Central trial contact

Chin-Song Lu, MD

Data sourced from clinicaltrials.gov

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