Parkinson's Disease (PD)NCT06118294
Efficacy of Probiotics for Parkinson Disease (PD)
A study testing probiotics in people with Parkinson's Disease (PD) and Movement Disorders, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
In previous clinical studies, PS128 has been reported to ameliorate motor deficits in Parkinson's disease (PD). PS23 has been reported to delay some age-related disorders. On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the… Read more about this study
- Who is it for?
- Ages 41 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD), Movement Disorders, Depression
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Nov 2023to 30 Oct 2026
- 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 41 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age between 41-80 years old and at least the elementary education level.
- Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 3 as rated.
Who cannot join
- Diagnosed before 40 years old.
- Used probiotic products in powder, capsule, or tablet form within four weeks.
- Have taken antibiotics within four weeks.
- Those who are not suitable to participate in the research are judged by PI.
Trial locations and contacts
1 site in 1 country.
About this study
In previous clinical studies, PS128 has been reported to ameliorate motor deficits in Parkinson's disease (PD). PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
Read the detailed description
The gut microbiota plays important roles in gastrointestinal homeostasis, essential physiological processes and CNS function, and affects the gut-brain axis via neural, immune and endocrine pathways giving rise to the microbiota-gut-brain-axis (MGBA). Combining the MGBA concept and the theory that Parkinson's disease (PD) is derived in the gut, researchers have studied the relationship between the gut microbiota and the PD neurodegenerative process. Probiotics are live microorganisms that confer health benefits on the host and can improve host physical and mental health by affecting MGBA homeostasis. Lactobacillus plantarum PS128 (PS128) and Lactobacillus paracasei PS23 (PS23) are specific probiotics, known as a psychobiotic, which has been demonstrated to alleviate depression- and anxiety-like behaviors in mouse model. Furthermore, PS128 alleviated motor deficits, nigrostriatal dopaminergic neuronal cell death, and striatal dopamine reduction in the MPTP mouse model of Parkinson's disease. In previous clinical studies, PS128 has been reported to ameliorate motor deficits in PD. PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
The eligible participants will be administered with probiotics capsules for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment. Blood and stool samples will be collected before and after the intervention for biochemical parameters.
- Conditions
- Parkinson's Disease (PD), Movement Disorders, Depression, Anxiety
- Being tested
- probiotics, Placebo
- Medical subject headings
- Parkinson Disease, Movement Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
>30 billion CFU/capsule
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | daily ingestion of 2 capsules of probiotics (>30 billion CFU/capsule) Receives: Dietary Supplement: probiotics |
| Placebo | Placebo comparator | daily ingestion of 2 capsules which 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: From Baseline to 12 Weeks Assessed
Secondary outcomes (11)
Clinical Global Impression scales of Severity rated by clinician（CGI）
The CGIC is a single-item questionnaire that asks the investigator to assess a patient's PD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit.
Measured: From Baseline to 12 Weeks Assessed
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.Scale UPDRS the sum of parts I, II and III ranges from 0 to 176. The UPDRS score has three components, each consisting of questions with 0-4 point scale. Part I assesses mentation, behavior, and mood; Part II assesses activities of daily; and Part III assesses motor abilities. Where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
Measured: From Baseline to 12 Weeks Assessed
Q-LES-Q
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Measured: From Baseline to 12 Weeks Assessed
Visual Analogue Scale for GI symptoms, VAS-GI
Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics
Measured: From Baseline to 12 Weeks Assessed
PGI-C
The PGIC is a scale participants use to rate the level of change they have experienced following treatment. The PGIC is a 7-point scale from 1 (very much better) to 7 (very much worse).
Measured: From Baseline to 12 Weeks Assessed
PHQ-9
Measure for Major Depressive Disorder from questionnaire responses, to measure the prevalence of clinically significant depression defined as a PHQ-9 score of equal to or greater than 10.
Measured: From Baseline to 12 Weeks Assessed
Differences in the State and Trait Anxiety Index (STAI)
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: From Baseline to 12 Weeks Assessed
Difference in Oxidative stress - blood level of HSCRP
To assess inflammation indicators, used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: From Baseline to 12 Weeks Assessed
Gut microbiota
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics
Measured: From Baseline to 12 Weeks Assessed
Level of Growth Differentiation Factor-15
Level of Growth Differentiation Factor-15
Measured: From Baseline to 12 Weeks Assessed
brain-derived neurotropic factor (BDNF)
Measurement BDNF level in serum
Measured: From Baseline to 12 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start8 Nov 2023 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Why it stopped: PI has retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 300 Participants are assigned to the probiotics and a placebo group, under the double-blind trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Principal investigator, Sheylin Wu, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118294
- Sponsor's protocol ID
- 230723
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2023
- Last updated
- 23 Apr 2024
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics for Parkinson Disease (PD)
- ClinicalTrials.gov ID
- NCT06118294
- Acronym / sponsor ID
- 230723
- Conditions
- Parkinson's Disease (PD), Movement Disorders, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has retired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 8 Nov 2023 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Nov 2023 (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.
In previous clinical studies, PS128 has been reported to ameliorate motor deficits in Parkinson's disease (PD). PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
Detailed description
The gut microbiota plays important roles in gastrointestinal homeostasis, essential physiological processes and CNS function, and affects the gut-brain axis via neural, immune and endocrine pathways giving rise to the microbiota-gut-brain-axis (MGBA). Combining the MGBA concept and the theory that Parkinson's disease (PD) is derived in the gut, researchers have studied the relationship between the gut microbiota and the PD neurodegenerative process. Probiotics are live microorganisms that confer health benefits on the host and can improve host physical and mental health by affecting MGBA homeostasis. Lactobacillus plantarum PS128 (PS128) and Lactobacillus paracasei PS23 (PS23) are specific probiotics, known as a psychobiotic, which has been demonstrated to alleviate depression- and anxiety-like behaviors in mouse model. Furthermore, PS128 alleviated motor deficits, nigrostriatal dopaminergic neuronal cell death, and striatal dopamine reduction in the MPTP mouse model of Parkinson's disease. In previous clinical studies, PS128 has been reported to ameliorate motor deficits in PD. PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
The eligible participants will be administered with probiotics capsules for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment. Blood and stool samples will be collected before and after the intervention for biochemical parameters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 300 Participants are assigned to the probiotics and a placebo group, under the double-blind trial.
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: probioticsdaily ingestion of 2 capsules of probiotics (>30 billion CFU/capsule) |
| Placebo | Placebo comparator | Dietary Supplement: Placebodaily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose |
Who may qualify
- Ages
- 41 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The age between 41-80 years old and at least the elementary education level.
- Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stage between 1 and 3 as rated.
Key exclusion criteria (4 listed)
- Diagnosed before 40 years old.
- Used probiotic products in powder, capsule, or tablet form within four weeks.
- Have taken antibiotics within four weeks.
- Those who are not suitable to participate in the research are judged by PI.
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 |
|---|---|---|
| probiotics>30 billion CFU/capsule | Dietary supplement | Probiotics |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
UPDRS III
Time frame: From Baseline to 12 Weeks Assessed
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.
11 secondary outcomes
Clinical Global Impression scales of Severity rated by clinician（CGI）
Time frame: From Baseline to 12 Weeks Assessed
UPDRS I-IV
Time frame: From Baseline to 12 Weeks Assessed
Q-LES-Q
Time frame: From Baseline to 12 Weeks Assessed
Visual Analogue Scale for GI symptoms, VAS-GI
Time frame: From Baseline to 12 Weeks Assessed
PGI-C
Time frame: From Baseline to 12 Weeks Assessed
PHQ-9
Time frame: From Baseline to 12 Weeks Assessed
Differences in the State and Trait Anxiety Index (STAI)
Time frame: From Baseline to 12 Weeks Assessed
Difference in Oxidative stress - blood level of HSCRP
Time frame: From Baseline to 12 Weeks Assessed
Gut microbiota
Time frame: From Baseline to 12 Weeks Assessed
Level of Growth Differentiation Factor-15
Time frame: From Baseline to 12 Weeks Assessed
brain-derived neurotropic factor (BDNF)
Time frame: From Baseline to 12 Weeks Assessed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson's Disease (PD)
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
Parkinson Disease
Not yet recruiting
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
Parkinson Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Parkinson's Disease (PD) and Movement Disorders, run by Changhua Christian Hospital 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 23 Apr 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS III (time frame: From Baseline to 12 Weeks Assessed). 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 23 Apr 2024.