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Status unknownNCT04722198Updated Jan 25, 2021

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

An interventional study of PS128 in Early Onset Parkinson Disease, sponsored by Professor Lu Neurological Clinic. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by Professor Lu Neurological Clinic · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Early Onset Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Professor Lu Neurological Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    PS128

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

    Dietary Supplement: PS128

Interventions

  • Dietary supplementPS128

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. TUG

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and Post-12 weeks

  2. 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.

    Time frame: Baseline and Post-12 weeks

  3. 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.

    Time frame: Baseline and Post-12 weeks

  4. 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).

    Time frame: Baseline and Post-12 weeks

  5. 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."

    Time frame: Post-12 weeks

07

Study locations

1 of 1 sites recruiting
  • Professor Lu Neurological Clinic
    Taoyuan City, Guishan Dist. 333, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04722198
Lead sponsor
Professor Lu Neurological Clinic
Responsible party
CHIN-SONG LU (Professor, Professor Lu Neurological Clinic) — Principal investigator
First posted
Jan 25, 2021
Start date
Oct 27, 2020
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jan 25, 2021

Study contacts

Chin-Song Lu, MD
Contact
cslu.public@gmail.com
886-3-3960388

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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