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

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.

Study Overview

• Status: Recruiting
• Conditions: Gut Microbiota; Parkinson Disease (PD); Probiotic
• Intervention / Treatment: Dietary supplement: Y7; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Yu Huang, PhD; Phone Number: 7350 02-27361661; Email: maggieh323@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Taipei Medical University Hospital; Phone Number: +886 +2 27372181; Email: ihc@h.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subject Inclusion Criteria:

1. Age between 30-85 years old.
2. Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr scale stage 1-3).
3. Brain MRI confirms striatal degeneration in the basal ganglia region, with no history of stroke.
4. Responds to Parkinson's disease-related medications (e.g., Levodopa).
5. Free of any major or acute illnesses.
6. Able to comply with the 12 weeks intervention and required assessments for the study.

Exclusion Criteria:

1. Unable to complete interviews or has mobility issues.
2. Presence of major or acute illness before or during the study.
3. Co-existing intestinal co-infections, such as CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus.
4. Allergic to the intervention product.
5. Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson Disease Probiotic product intervention group (Y); 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.	Dietary supplement: Y7; 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).
Placebo Comparator: Parkinson Disease group (P); P group must conform to inclusion criteria and exclusion criteria. P group need to finish pre test and post test.	Dietary supplement: Placebo; Take two servings of the placebo product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Taipei Medical University Hospital; Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; Parkinson's Disease; Gut microbiota
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: N202405094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing may be considered on a case-by-case basis upon reasonable request and subject to a formal data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No