Effects of PS128 on Parkinsonian Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT03566589
• Date of registration: 12/06/2018
• Prospective Registration: Yes
• Primary sponsor: Professor Lu Neurological Clinic
• Public title: Effects of PS128 on Parkinsonian Symptoms
• Scientific title: Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot Study
• Date of first enrolment: July 2, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03566589
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Taiwan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Between ages of 40-80 years old

- Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage
between 1 and 2.5 as rated during an "on" period

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 current or history of inflammatory bowel disease

- Have history of cancer

- Have undergone surgery of liver, bladder, or gastrointestinal tract

- 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Dietary Supplement: Lactobacillus plantarum PS128

Primary Outcome(s)

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 12 Assessed On Medication [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Score From Baseline to Week 12 Assessed On Medication [Time Frame: to Week 12 Assessed On Medication]

Change in Patient Global Impression of Change (PGIC) Score From Baseline to Week 12 Assessed On Medication [Time Frame: to Week 12 Assessed On Medication]

Secondary ID(s)

PS128-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors