Actively Recruiting
Developing Precision Microbiota-Based Cocktail Therapy to Delay Parkinson's Disease Progression Using Probiotic Y7, Tryptophan, and Branched-Chain Amino Acids in Early Stage Patients
Led by Taipei Medical University · Updated on 2026-06-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Taipei Medical University
Lead Sponsor
T
Taipei Medical University Shuang Ho Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a cocktail formula containing the probiotic Y7 combined with tryptophan and branched-chain amino acids in early-stage Parkinson's disease patients. This research aims to assess the effects of this supplement on motor, cognitive, and non-motor functions. The study will also develop a personalized prognosis prediction model for Parkinson's disease using clinical, biochemical, genetic, microbial, and metabolite data analyzed with machine learning to predict disease status 12 weeks after treatment. The trial is a two-arm, randomized controlled study involving 120 patients with Parkinson's disease stages 1 to 3. Participants are divided into an intervention group receiving the probiotic Y7 cocktail and a control group receiving a placebo. Both groups take two servings daily after breakfast and dinner for 12 weeks. Pre- and post-intervention assessments will be conducted to evaluate changes. Participants will undergo baseline assessments two weeks before starting the intervention and follow-up assessments two weeks after completion. Researchers will measure changes in motor and non-motor symptoms using questionnaires, cognitive tests like the Montreal Cognitive Assessment and Mini-Mental State Examination, sleep and constipation symptoms, nutritional status, body composition, dietary intake, gut microbiota, fecal and serum biomarkers, biochemical blood markers, immune profiles, and adverse events over the 12-week intervention. The study aims to understand treatment effects and predict individual disease progression.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 85 years old
- Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr stage 1 to 3)
- Brain MRI shows striatal degeneration in the basal ganglia without history of stroke
- Responds to Parkinson's disease medications such as Levodopa
- Free from major or acute illnesses
- Able to complete the 12-week intervention and all required assessments
You will not qualify if you...
- Unable to complete interviews or has mobility difficulties
- Has major or acute illness before or during the study
- Has intestinal co-infections like CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus
- Allergic to the probiotic intervention product
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take two servings daily of either the probiotic product containing Y7, tryptophan, and branched-chain amino acids or a placebo for 12 weeks.
1 baseline visit and 1 follow-up visit at Week 12
Duration - 2 weeks
Participants complete post-intervention assessments two weeks after treatment ends to evaluate changes in symptoms and biochemical markers.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
H
Hui Yu Huang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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