Trial Outcomes & Findings for PS128 May Improve Off Duration on Parkinson's Disease (NCT NCT04389762)

NCT ID: NCT04389762

Last Updated: 2025-08-17

Results Overview

The UPDRS scores is a rating tool used to gauge the course of Parkinson's disease in patients. The minimum total score possible is 0 and the maximum total score possible is 199. Higher values represent a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Baseline to Week 12 assessed on medication

Results posted on

2025-08-17

Participant Flow

Participants aged between 40 to 80 who were diagnosed with idiopathic Parkinson's Disease with daily off periods more than 3 hours were enrolled from June 2019 to June 2020. All the participants were administered two capsules containing PS128 (30 billion colony-forming units per capsule) daily for 12 weeks.

Participant milestones

Participant milestones
Measure	PS128 daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=25 Participants
Age, Categorical >=65 years	3 Participants n=25 Participants
Sex: Female, Male Female	8 Participants n=25 Participants
Sex: Female, Male Male	17 Participants n=25 Participants
Region of Enrollment Taiwan	25 participants n=25 Participants
Age at onset	51.72 years STANDARD_DEVIATION 6.59 • n=25 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12 assessed on medication

Population: Participants who completed the 12-week intervention were analyzed.

The UPDRS scores is a rating tool used to gauge the course of Parkinson's disease in patients. The minimum total score possible is 0 and the maximum total score possible is 199. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in Unified Parkinson's Disease Rating Scale (UPDRS) pre	33.00 score on a scale Standard Deviation 10.65
Change in Unified Parkinson's Disease Rating Scale (UPDRS) post	29.24 score on a scale Standard Deviation 10.26

PRIMARY outcome

Timeframe: Baseline to Week 12 assessed off medications

Population: Participants who completed the 12-week intervention were analyzed.

The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. The minimum possible total score is 0 and the maximum possible total score is 108. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "OFF" Period pre	27.16 score on a scale Standard Deviation 7.11
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "OFF" Period post	24.08 score on a scale Standard Deviation 8.20

PRIMARY outcome

Timeframe: Baseline to Week 12 assessed on medications

Population: Participants who completed the 12-week intervention were analyzed.

The UPDRS III scores is subscores of UPDRS, it indicates motor function of PD symptoms. The minimum possible total score is 0 and the maximum possible total score is 108. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "ON" Period pre	17.56 score on a scale Standard Deviation 6.92
Change in Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) "ON" Period post	15.00 score on a scale Standard Deviation 7.76

PRIMARY outcome

Timeframe: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self

Population: Participants who completed the 12-week intervention were analyzed.

"ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states. Higher hours in "OFF" period represent better outcome.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in Patient "ON-OFF" Diary Recording "OFF" Period pre	6.52 hours Standard Deviation 1.66
Change in Patient "ON-OFF" Diary Recording "OFF" Period post	5.72 hours Standard Deviation 2.64

PRIMARY outcome

Timeframe: Record for 3 consecutive days prior to Baseline and Week 12 visits by patient-self

Population: Participants who completed the 12-week intervention were analyzed.

Outcome Measure Description: "ON-OFF" motor fluctuations are rapid changes in mobility during which PD patients report sudden shifts from adequate mobility to mobility, usually within a few seconds or minutes. The 24-hour diary is divided into 30-minute sections and only mark one answer for each half hour period. It is to know how much time each patient spends in the different Parkinson's states. Higher hours in "ON" period represent worse outcome.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in Patient "ON-OFF" Diary Recording "ON" Period pre	9.92 hours Standard Deviation 1.76
Change in Patient "ON-OFF" Diary Recording "ON" Period psot	10.76 hours Standard Deviation 1.68

SECONDARY outcome

Timeframe: Baseline to Week 12 assessed on Medication

Population: Participants who completed the 12-week intervention were analyzed.

NMS-Quest is a 30-item Screening tool for non-motor symptoms of Parkinson's disease. The minimum total score possible is 0 and the maximum total score possible is 30. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score pre	6.84 score on a scale Standard Deviation 4.65
Change in Nonmotor Symptoms: 30-item Screening Questionnaire (NMS-Quest) Total Score post	6.28 score on a scale Standard Deviation 4.35

SECONDARY outcome

Timeframe: Baseline to Week 12 assessed on Medication

Population: Participants who completed the 12-week intervention were analyzed.

The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. The minimum possible score is 0 and the maximum possible score is 100. Higher values represent a worse outcome."

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Change in The Parkinson's Disease Questionnaire (PDQ-39) pre	19.86 score on a scale Standard Deviation 9.60
Change in The Parkinson's Disease Questionnaire (PDQ-39) post	14.18 score on a scale Standard Deviation 8.61

SECONDARY outcome

Timeframe: Week 12 assessed on Medication

Population: Participants who completed the 12-week intervention were included.

The Patient Global Impression of Change (PGI-C) consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome. We exploratorily investigate participants' subjective impression after intervention by PGI-C. The percentage of participant's response in each category, such as "very much improved", "minimally improved", "no change", or "minimally worse" were used to draw an overall conclusion of the intervention potential in the open-arm trial.

Outcome measures

Outcome measures
Measure	PS128 n=25 Participants daily ingestion of Lactobacillus plantarum PS128 capsules daily ingestion of Lactobacillus plantarum PS128: daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Patient Global Impression of Change (PGI-C) Very much improved	1 Participants
Patient Global Impression of Change (PGI-C) Much improved	4 Participants
Patient Global Impression of Change (PGI-C) Minimally improved	12 Participants
Patient Global Impression of Change (PGI-C) No change	7 Participants
Patient Global Impression of Change (PGI-C) Minimally worse	1 Participants

Adverse Events

PS128

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Lu

Professor Lu Neurological Clinic

Phone: +886-3-396-0388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place