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| Name | Class |
|---|---|
| Taipei Medical University Shuang Ho Hospital | OTHER |
| Taipei Medical University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y7 | Dietary 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The baseline assessments were conducted two weeks prior to the intervention, and the post-intervention assessments were completed two weeks after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 after intervention. |
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Inclusion Criteria:
Subject Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Yu Huang, PhD | Contact | 02-27361661 | 7350 | maggieh323@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
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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| Placebo | Dietary Supplement | Take two servings of the placebo product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Week 12 after intervention. |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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