Lactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot Study
Phase: NA
Conditions: Parkinson Disease
Sponsor: Professor Lu Neurological Clinic

The Add-On Effect of Lactobacillus plantarum PS128 in Patients 
With Parkinson’s Disease: A Pilot Study 
NCT04389762 
December 31, 2021 
1. 
Assessment of Outcomes 
In this study, the primary measurements were the Unified Parkinson’s Disease Rating 
Scale part III (UPDRS-III) motor scores and changes in patient’s “ON-OFF” diary 
recordings, and modified Hoehn and Yahr scale (mHYS). The secondary 
measurements were the 39-item Parkinson’s Disease Questionnaire (PDQ-39), Non-
Motor Symptoms Scale (NMSS), BDI-II, patient assessment of constipation 
symptoms (PAC-SYM), Patient Global Impression of Change (PGI-C), and other 
metabolic profiles. All clinical assessments were performed after 12 h of overnight 
withdrawal from antiparkinsonian medications (24 h of withdrawal was needed if the 
participants were taking prolonged release dopaminergic agonists). Therefore, 
UPDRS-III and mHYS were scored in the OFF state the next morning as well as the 
metabolic profiles. Then, the medications were self-administered by each patient 
before the secondary measurements. The UPDRS, mHYS, PDQ-39, NMSS, BDI-II, 
PAC-SYM, and PGI-C were scored 40–60min later in the patients’ best ON state. For 
safety assessment, physical and neurological examinations were performed to 
evaluate the overall health of the subjects at weeks 0 and 12. In addition, all subjects 
were actively monitored for the occurrence of adverse events by telephone at least 
once per week. 
2. 
Biochemical Measurements 
A blood sample of 15mL and a urine sample of 10mL were collected at weeks 0 and 
12. The serum high-sensitivity C-reactive protein level was determined by 
turbidimetric immunoassay. The plasma myeloperoxidase (MPO) and urinary 8-
hydroxy-2’-deoxyguanosine were measured by enzyme-linked immunosorbent assay. 
The plasma glutathione peroxidase and total antioxidant capacity were measured by 
Ransel test kits (Randox Laboratories Ltd., UK) and ferric-reducing ability, 
respectively. The urinary creatinine (CRE) level was determined by MeDiPro 
creatinine test. All procedures were performed according to the manufacturer’s 

instructions. 
3. 
Statistics Analysis 
For this clinical trial, all statistical analyses are conducted using SPSS software 
(Version 22.0, IBM Corp., Armonk, NY). Descriptive statistics are presented as mean 
± standard deviation (SD). The Wilcoxon signed-rank test is used for comparisons on 
ordinal scales when a significant difference is observed. This test is employed to 
evaluate changes in total UPDRS, UPDRS-I, UPDRS-II, UPDRS-III, UPDRS-IV, as 
well as subscores for tremor, rigidity, akinesia, and postural instability gait disorder 
(PIGD), mHYS, diary recordings, PDQ-39, BDI-II, and PAC-SYM from baseline 
(V0) to post-intervention (V1, 12 weeks). Effect sizes are calculated using Cohen's d, 
defined as the mean change divided by the SD. For nominal scale variables with 
significant differences, the chi-square test is applied, particularly for the NMSS. 
Paired Student's t-test is used to assess differences in metabolic parameters between 
baseline and after the probiotics intervention. All data are reported as the mean ± SD, 
with statistical significance set at p < 0.05.