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

NCT07619560 | Recruiting

• 1 other identifier: N202405094
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease (PD); Gut Microbiota; Probiotic

Keywords

Parkinson's Disease; Probiotics; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Change from Baseline to Week 12 in Montreal Cognitive Assessment Score in Patients with Parkinson's Disease

  Baseline and Week 12 after intervention.

• Change from Baseline to Week 12 in Mini-Mental State Examination Score in Patients with Parkinson's Disease

  Baseline and Week 12 after intervention.

• Change from Baseline to Week 12 in Non-Motor Symptoms Scale Score in Patients with Parkinson's Disease

  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

  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

  Baseline and Week 12 after intervention.

Study Arms (2)

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.

Dietary Supplement: Y7

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.

Dietary Supplement: Placebo

Interventions

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).

Parkinson Disease Probiotic product intervention group (Y)

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.

Parkinson Disease group (P)

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead
• Taipei Medical University Hospital: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Hui Yu Huang, PhD

CONTACT

02-27361661; maggieh323@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Medical University, graduate Institute of Metabolism and Obesity Sciences, Professor

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: June 2, 2026
• Study Start: May 20, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

TW (1)