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

N/ARecruitingNCT07619560

Taipei Medical University120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

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.