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

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ClinicalTrials.gov Identifier: NCT04722211
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
CHIN-SONG LU, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: PS128 Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PS128
Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg
Dietary Supplement: PS128
daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)

Placebo Comparator: placebo
The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose
Dietary Supplement: placebo
daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose




Primary Outcome Measures :
  1. UPDRS III [ Time Frame: 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.


  2. MHY [ Time Frame: 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.


  3. TUG [ Time Frame: 12 weeks ]
    Observe the patient's postural stability, gait, stride length, sway and test cut-off times.


Secondary Outcome Measures :
  1. UPDRS I-IV [ Time Frame: 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.


  2. SCL-90-R [ Time Frame: 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.


  3. CPSQI [ Time Frame: 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.

  4. VAS-GI [ Time Frame: 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).

  5. PGIC [ Time Frame: 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."



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722211


Locations
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Taiwan
Professor Lu Neurological Clinic Recruiting
Taoyuan City, Guishan Dist., Taiwan, 333
Contact: CHIN-SONG LU, MD    033960388    lucs.clinic@gmail.com   
Sponsors and Collaborators
Professor Lu Neurological Clinic
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Responsible Party: CHIN-SONG LU, Professor, Professor Lu Neurological Clinic
ClinicalTrials.gov Identifier: NCT04722211    
Other Study ID Numbers: PS128-03
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHIN-SONG LU, Professor Lu Neurological Clinic:
probiotics, parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases