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

Taipei Medical University

Status: Enrolling

Conditions: Gut Microbiota; Parkinson Disease (PD); Probiotic

Treatments: Dietary Supplement: Y7; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07619560

N202405094

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Parkinson Disease Probiotic product intervention group (Y)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Y7

Parkinson Disease group (P)

Placebo Comparator group

Description:

P group must conform to inclusion criteria and exclusion criteria. P group need to finish pre test and post test.

Treatment:

Dietary Supplement: Placebo