Parkinson Disease (PD)NCT07619560
Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease (PD) - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage PD Patients
A study testing Y7 in people with Parkinson Disease (PD) and Gut Microbiota, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease (PD), Gut Microbiota, Probiotic
- What is being tested?
- Y7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject Inclusion Criteria:
- Age between 30-85 years old.
- Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr scale stage 1-3).
- Brain MRI confirms striatal degeneration in the basal ganglia region, with no history of stroke.
- Responds to Parkinson's disease-related medications (e.g., Levodopa).
- Free of any major or acute illnesses.
- Able to comply with the 12 weeks intervention and required assessments for the study.
Who cannot join
- Unable to complete interviews or has mobility issues.
- Presence of major or acute illness before or during the study.
- Co-existing intestinal co-infections, such as CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus.
- Allergic to the intervention product.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Taipei Medical University Hospital, +886 +2 27372181, ihc@h.tmu.edu.tw
About this study
Official title: Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage Parkinson's Disease Patient
Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. The study aims to recruit 120 patients (stage 1-3) and employ a two-arm, randomized controlled trial (RCT) design, dividing subjects into intervention and control groups for a 12 weeks trial period. Commercial development will be contingent upon the clinical trial outcomes, evaluating whether the product offers clinical benefits such as delaying Parkinson's disease progression in motor, cognitive, and non-motor functions. Additionally, a personalized and precise prognosis prediction model for Parkinson's disease will be established. This model will gather comprehensive clinical data, including motor function assessments (functional tests, UPDRS), biochemical markers, questionnaire responses, and genotype data (TPM array), as well as metabolite and microbial data. Through integrated analysis of this biological information using machine learning techniques, a personalized and accurate prognosis prediction model for Parkinson's disease will be developed. This model will predict the disease status of PD patients 12 weeks later, accounting for factors such as cocktail therapy. The results will empower PD patients to understand their individual disease progression and treatment prognosis, enabling them to prepare accordingly. Moreover, this model will aid researchers in identifying patient profiles more likely to benefit from treatment, thereby enhancing the evaluation of the efficacy and applicability of cocktail therapy.
- Conditions
- Parkinson Disease (PD), Gut Microbiota, Probiotic
- Being tested
- Y7, Placebo
- Keywords
- Parkinson's Disease, Probiotics, Gut microbiota
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y7Dietary supplement
Take two servings of the probiotic product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks.
Ingredients of the probiotic product: Probiotic strain Y7, tryptophan, and BCAAs (valine, leucine, and isoleucine).
PlaceboDietary supplement
Take two servings of the placebo product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease Probiotic product intervention group (Y) | Experimental | Y group must conform to inclusion criteria and exclusion criteria. Need to intervene "probiotic Y7, tryptophan and branched-chain amino acid" cocktail formula supplementation. Probiotic product intervention group need to finish pre test and post test. Receives: Dietary Supplement: Y7 |
| Parkinson Disease group (P) | Placebo comparator | P group must conform to inclusion criteria and exclusion criteria. P group need to finish pre test and post test. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Questionnaire-Based Changes in Motor and Non-Motor Symptoms in Parkinson's Disease
Change in Unified Parkinson's Disease Rating Scale (UPDRS) motor score from baseline to 12 weeks
Measured: The baseline assessments were conducted two weeks prior to the intervention, and the post-intervention assessments were completed two weeks after the intervention.
Secondary outcomes (25)
Change from Baseline to Week 12 in Montreal Cognitive Assessment Score in Patients with Parkinson's Disease
The Montreal Cognitive Assessment is used to evaluate cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. A score below 26 suggests possible cognitive impairment.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Mini-Mental State Examination Score in Patients with Parkinson's Disease
The Mini-Mental State Examination is used to assess global cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance and lower scores indicating greater cognitive impairment.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Non-Motor Symptoms Scale Score in Patients with Parkinson's Disease
The Non-Motor Symptoms Scale is used to assess the frequency and severity of non-motor symptoms in patients with Parkinson's disease. Higher scores indicate greater non-motor symptom burden and worse clinical condition.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Parkinson's Disease Questionnaire-39 Score in Patients with Parkinson's Disease
The Parkinson's Disease Questionnaire-39 is used to evaluate health-related quality of life in patients with Parkinson's disease. Scores are transformed to a 0 to 100 scale, with higher scores indicating poorer quality of life.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Parkinson's Disease Sleep Scale Score in Patients with Parkinson's Disease
The Parkinson's Disease Sleep Scale is used to evaluate sleep disturbances in patients with Parkinson's disease. The scale includes 15 items, each scored from 0 to 10. Higher scores indicate better sleep quality and fewer sleep-related symptoms.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Patient Assessment of Constipation Symptoms Score in Patients with Parkinson's Disease
The Patient Assessment of Constipation Symptoms questionnaire is used to assess constipation-related gastrointestinal symptoms. Higher scores indicate more severe constipation symptoms and worse gastrointestinal status.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Bristol Stool Scale Score in Patients with Parkinson's Disease
The Bristol Stool Scale is used to classify stool form. Scores range from 1 to 7, with lower scores indicating harder stools and higher scores indicating looser stools. Scores around 3 to 4 generally indicate more normal stool form.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Mini Nutritional Assessment Score in Patients with Parkinson's Disease
The Mini Nutritional Assessment is used to evaluate nutritional status. Higher scores indicate better nutritional status, whereas lower scores indicate increased risk of malnutrition or poorer nutritional condition.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Body Composition Parameters in Patients with Parkinson's Disease
Body composition will be assessed using InBody analysis. Parameters may include body weight, skeletal muscle mass, body fat mass, and body mass index. Each parameter will be reported separately using its corresponding unit of measurement.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Dietary Intake Based on 24-Hour Dietary Recall in Patients with Parkinson's Disease
Dietary intake will be assessed using the 24-hour dietary recall method. Nutrient intake, including total energy, macronutrients, and selected nutrients, will be analyzed. Each dietary variable will be reported separately using its corresponding unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Gut Microbiota Composition in Patients with Parkinson's Disease
Gut microbiota composition will be assessed using shotgun metagenomic sequencing of fecal samples. Changes in microbial diversity and relative abundance of bacterial taxa will be evaluated to explore gut microbiota alterations after intervention.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Fecal Short-Chain Fatty Acid Levels in Patients with Parkinson's Disease
Fecal short-chain fatty acids will be measured to evaluate changes in gut microbiota-derived metabolites after intervention. Each short-chain fatty acid will be reported separately using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Fecal Bile Acid Levels in Patients with Parkinson's Disease
Fecal bile acids will be measured to evaluate changes in gut microbiota-related metabolic activity after intervention. Each bile acid will be reported separately using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Branched-Chain Amino Acid Levels in Patients with Parkinson's Disease
Serum branched-chain amino acids, including valine, leucine, and isoleucine, will be measured to evaluate changes in amino acid metabolism after intervention. Each metabolite will be reported separately using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Tryptophan Level in Patients with Parkinson's Disease
Serum tryptophan will be measured to evaluate changes in tryptophan metabolism after intervention. Tryptophan is an essential amino acid involved in serotonin, kynurenine, and indole-related metabolic pathways. Results will be reported using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Tyrosine Level in Patients with Parkinson's Disease
Serum tyrosine will be measured to evaluate changes in amino acid metabolism after intervention. Tyrosine is related to catecholamine synthesis and may reflect metabolic alterations associated with Parkinson's disease. Results will be reported using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Serotonin Level in Patients with Parkinson's Disease
Serum serotonin will be measured to evaluate changes in tryptophan-related metabolic pathways after intervention. Results will be reported using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Indole-3-Propionic Acid Level in Patients with Parkinson's Disease
Serum indole-3-propionic acid will be measured to evaluate changes in gut microbiota-derived tryptophan metabolites after intervention. Results will be reported using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Rab35 Level in Patients with Parkinson's Disease
Serum Rab35 will be measured as an exploratory biomarker related to intracellular trafficking and protein processing. Results will be reported using its corresponding concentration unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in General Biochemical Blood Marker Levels in Patients with Parkinson's Disease
General biochemical blood markers, including AST, ALT, albumin, creatinine, BUN, uric acid, total cholesterol, triglycerides, HDL, LDL, HbA1c, glucose, insulin, total bilirubin, and ApoE, will be measured. Each marker will be reported separately using its corresponding unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Inflammatory Marker Levels in Patients with Parkinson's Disease
Inflammatory markers, including tumor necrosis factor-alpha, transforming growth factor-beta, zonulin, neurofilament light chain, and calprotectin, will be measured to evaluate changes in systemic inflammation, gut barrier function, and neurodegeneration-related biomarkers. Each marker will be reported separately using its corresponding unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Antioxidant Marker Levels in Patients with Parkinson's Disease
Antioxidant markers, including catalase, glutathione peroxidase, and superoxide dismutase, will be measured to evaluate changes in antioxidant defense status after intervention. Each marker will be reported separately using its corresponding unit.
Measured: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Immune Cell Profiles Measured by Flow Cytometry in Patients with Parkinson's Disease
Immune cell profiles will be assessed using flow cytometry to evaluate changes in immune status after intervention. Each immune cell population will be reported separately as a percentage or absolute count, as appropriate.
Measured: Baseline and Week 12 after intervention.
Incidence of Adverse Events During the 12-Week Intervention Period in Patients with Parkinson's Disease
Adverse events will be assessed throughout the intervention period to evaluate the safety and tolerability of the intervention. Events such as diarrhea, nausea, abdominal discomfort, or other self-reported symptoms will be recorded.
Measured: From baseline to Week 12 after intervention.
Change from Baseline to Week 12 in Clinical Global Impression Score in Patients with Parkinson's Disease
The Clinical Global Impression scale will be used to evaluate overall clinical status and treatment response. Higher or lower scores will be interpreted according to the specific CGI subscale used in the study.
Measured: Baseline and Week 12 after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start20 May 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Shuang Ho Hospital, Taipei Medical University Hospital
- Responsible party
- Principal investigator, Huang, Hui-Yu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619560
- Sponsor's protocol ID
- N202405094
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing may be considered on a case-by-case basis upon reasonable request and subject to a formal data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage Parkinson's Disease Patient
- ClinicalTrials.gov ID
- NCT07619560
- Acronym / sponsor ID
- N202405094
- Conditions
- Parkinson Disease (PD), Gut Microbiota, Probiotic
- Keywords
- Parkinson's Disease, Probiotics, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taipei Medical University Shuang Ho Hospital, Taipei Medical University Hospital
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 Jun 2026 (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.
Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. The study aims to recruit 120 patients (stage 1-3) and employ a two-arm, randomized controlled trial (RCT) design, dividing subjects into intervention and control groups for a 12 weeks trial period. Commercial development will be contingent upon the clinical trial outcomes, evaluating whether the product offers clinical benefits such as delaying Parkinson's disease progression in motor, cognitive, and non-motor functions. Additionally, a personalized and precise prognosis prediction model for Parkinson's disease will be established. This model will gather comprehensive clinical data, including motor function assessments (functional tests, UPDRS), biochemical markers, questionnaire responses, and genotype data (TPM array), as well as metabolite and microbial data. Through integrated analysis of this biological information using machine learning techniques, a personalized and accurate prognosis prediction model for Parkinson's disease will be developed. This model will predict the disease status of PD patients 12 weeks later, accounting for factors such as cocktail therapy. The results will empower PD patients to understand their individual disease progression and treatment prognosis, enabling them to prepare accordingly. Moreover, this model will aid researchers in identifying patient profiles more likely to benefit from treatment, thereby enhancing the evaluation of the efficacy and applicability of cocktail therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease Probiotic product intervention group (Y) | Experimental | Dietary Supplement: Y7Y group must conform to inclusion criteria and exclusion criteria. Need to intervene "probiotic Y7, tryptophan and branched-chain amino acid" cocktail formula supplementation. Probiotic product intervention group need to finish pre test and post test. |
| Parkinson Disease group (P) | Placebo comparator | Dietary Supplement: PlaceboP group must conform to inclusion criteria and exclusion criteria. P group need to finish pre test and post test. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 30-85 years old.
- Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr scale stage 1-3).
- Brain MRI confirms striatal degeneration in the basal ganglia region, with no history of stroke.
- Responds to Parkinson's disease-related medications (e.g., Levodopa).
- Free of any major or acute illnesses.
Key exclusion criteria (5 listed)
- Unable to complete interviews or has mobility issues.
- Presence of major or acute illness before or during the study.
- Co-existing intestinal co-infections, such as CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus.
- Allergic to the intervention product.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Y7Take two servings of the probiotic product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks. Ingredients of the probiotic product: Probiotic strain Y7, tryptophan, and BCAAs (valine, leucine, and isoleucine). | Dietary supplement | Parkinson Disease Probiotic product intervention group (Y) |
| PlaceboTake two servings of the placebo product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks. | Dietary supplement | Parkinson Disease group (P) |
Primary outcome
Assessment of Questionnaire-Based Changes in Motor and Non-Motor Symptoms in Parkinson's Disease
Time frame: The baseline assessments were conducted two weeks prior to the intervention, and the post-intervention assessments were completed two weeks after the intervention.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) motor score from baseline to 12 weeks
25 secondary outcomes
Change from Baseline to Week 12 in Montreal Cognitive Assessment Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Mini-Mental State Examination Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Non-Motor Symptoms Scale Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Parkinson's Disease Questionnaire-39 Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Parkinson's Disease Sleep Scale Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Patient Assessment of Constipation Symptoms Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Bristol Stool Scale Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Mini Nutritional Assessment Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Body Composition Parameters in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Dietary Intake Based on 24-Hour Dietary Recall in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Gut Microbiota Composition in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Fecal Short-Chain Fatty Acid Levels in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Fecal Bile Acid Levels in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Branched-Chain Amino Acid Levels in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Tryptophan Level in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Tyrosine Level in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Serotonin Level in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Indole-3-Propionic Acid Level in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Rab35 Level in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in General Biochemical Blood Marker Levels in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Inflammatory Marker Levels in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Antioxidant Marker Levels in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Immune Cell Profiles Measured by Flow Cytometry in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Incidence of Adverse Events During the 12-Week Intervention Period in Patients with Parkinson's Disease
Time frame: From baseline to Week 12 after intervention.
Change from Baseline to Week 12 in Clinical Global Impression Score in Patients with Parkinson's Disease
Time frame: Baseline and Week 12 after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided. Data sharing may be considered on a case-by-case basis upon reasonable request and subject to a formal data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y7 in people with Parkinson Disease (PD) and Gut Microbiota, run by Taipei Medical University 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Yu Huang, PhD (02-27361661 ext. 7350, maggieh323@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Questionnaire-Based Changes in Motor and Non-Motor Symptoms in Parkinson's Disease (time frame: The baseline assessments were conducted two weeks prior to the intervention, and the post-intervention assessments were completed two weeks after the intervention.). 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 2 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.