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

Change in Unified Parkinson's Disease Rating Scale (UPDRS) motor score from baseline to 12 weeks

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Serum serotonin will be measured to evaluate changes in tryptophan-related metabolic pathways after intervention. Results will be reported using its corresponding concentration unit.

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.

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.

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.

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.

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.

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.

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.

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.