Parkinson DiseaseNCT04722211
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
A study testing PS128 in people with Parkinson Disease, run by Professor Lu Neurological Clinic at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PS128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jul 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Modified Hoehn \&Yahr stage, MHY 1-3
- 45-80 years old
- at least 9 years education
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Professor Lu Neurological Clinic
Taoyuan City, Guishan Dist., 333
CHIN-SONG LU, MD, 033960388, lucs.clinic@gmail.com
About this study
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Being tested
- PS128, placebo
- Keywords
- probiotics, parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS128Dietary supplement
daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)
placeboDietary supplement
daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| PS128 | Experimental | Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg Receives: Dietary Supplement: PS128 |
| placebo | Placebo comparator | The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS III
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The PART III is Motor sections.
Measured: 12 weeks
MHY
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
The modified Hoehn and Yahr scale included stages 1 through 5. to help describe the intermediate course of the disease.
Measured: 12 weeks
TUG
Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
Measured: 12 weeks
Secondary outcomes (5)
UPDRS I-IV
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.
Measured: Baseline and Post-12 weeks
SCL-90-R
The Symptom Checklist-90-Revised instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology.
The SCL-90-R is normed on individuals 13 years and older. It consists of 90 items and takes 12-15 minutes to administer.
Measured: Baseline and Post-12 weeks
CPSQI
The Chinese Version of the Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality.
Measured: Baseline and Post-12 weeks
VAS-GI
Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).
Measured: Baseline and Post-12 weeks
PGIC
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: Post-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start6 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Lu Neurological Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIN-SONG LU, Professor Lu Neurological Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722211
- Sponsor's protocol ID
- PS128-03
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT04722211
- Acronym / sponsor ID
- PS128-03
- Conditions
- Parkinson Disease
- Keywords
- probiotics, parkinson's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Professor Lu Neurological ClinicUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 120 Participants are assigned to the PS128 and a placebo group, under the double-blind trial.
| Arm | Type | Receives |
|---|---|---|
| PS128 | Experimental | Dietary Supplement: PS128Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg |
| placebo | Placebo comparator | Dietary Supplement: placeboThe placebo capsules only contained 425 ± 25 mg microcrystalline cellulose |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Modified Hoehn \&Yahr stage, MHY 1-3
- 45-80 years old
- at least 9 years education
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS128daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule) | Dietary supplement | PS128 |
| placebodaily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose | Dietary supplement | placebo |
Primary outcome
UPDRS III
Time frame: 12 weeks
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The PART III is Motor sections.
MHY
Time frame: 12 weeks
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The modified Hoehn and Yahr scale included stages 1 through 5. to help describe the intermediate course of the disease.
TUG
Time frame: 12 weeks
Observe the patient's postural stability, gait, stride length, sway and test cut-off times.
5 secondary outcomes
UPDRS I-IV
Time frame: Baseline and Post-12 weeks
SCL-90-R
Time frame: Baseline and Post-12 weeks
CPSQI
Time frame: Baseline and Post-12 weeks
VAS-GI
Time frame: Baseline and Post-12 weeks
PGIC
Time frame: Post-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS128 in people with Parkinson Disease, run by Professor Lu Neurological Clinic at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS III (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.