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

Professor Lu Neurological Clinic

Status: Unknown

Conditions: Parkinson Disease

Treatments: Dietary Supplement: PS128; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04722211

PS128-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo 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

placebo

Placebo Comparator group

Description:

The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose

Treatment:

Dietary Supplement: placebo