Clinical trial NCT04389762: PS128 May Improve Off Duration on Parkinson's Disease
Official title: Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Professor Lu Neurological Clinic
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the short term effects (12 Weeks) of Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.

Detailed description: This 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 treatment for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's Disease
* According to the record of ON / OFF diary for 3 consecutive days, the patient's daily off periods must be more than 3 hours a day.
* Between ages of 40-80 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

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline to Week 12 assessed on medication
measure: Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII)
timeFrame: Baseline to Week 12 assessed both off and on medications
measure: Change in Patient "ON-OFF" diary recording
timeFrame: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self
Secondary outcomes:
measure: Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score
timeFrame: Baseline to Week 12 assessed on Medication
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: Week 12 assessed on Medication
measure: Change in The Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline to Week 12 assessed on Medication
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Professor Lu Neurological Clinic
state: Guishan Dist.
Study officials:
affiliation: Professor Lu Neurological Clinic
name: Chin-Song Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu CS, Chang HC, Weng YH, Chen CC, Kuo YS, Tsai YC. The Add-On Effect of Lactobacillus plantarum PS128 in Patients With Parkinson's Disease: A Pilot Study. Front Nutr. 2021 Jun 30;8:650053. doi: 10.3389/fnut.2021.650053. eCollection 2021.