N/A
Completed N=26
PS128 May Improve Off Duration on Parkinson's Disease
Source: ClinicalTrials.gov NCT04389762 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Change in Unified Parkinson's Disease Rating Scale (UPDRS) — 33.00; 29.24 score on a scale — p=0.003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) |
33.00; 29.24 | 0.003 sig |
| PRIMARY Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "OFF" Period |
27.16; 24.08 | 0.004 sig |
| PRIMARY Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "ON" Period |
17.56; 15.00 | 0.007 sig |
| PRIMARY Change in Patient "ON-OFF" Diary Recording "OFF" Period |
6.52; 5.72 | 0.040 sig |
| PRIMARY Change in Patient "ON-OFF" Diary Recording "ON" Period |
9.92; 10.76 | 0.031 sig |
| SECONDARY Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score |
6.84; 6.28 | 0.115 |
| SECONDARY Change in The Parkinson's Disease Questionnaire (PDQ-39) |
19.86; 14.18 | 0.031 sig |
| SECONDARY Patient Global Impression of Change (PGI-C) |
1; 4; 12; 7; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04389762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.