NCT07619560 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
| NCT ID | NCT07619560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University |
| Condition | Parkinson Disease (PD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-05-20 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07619560 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 85 Years, studying Parkinson Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07619560 currently recruiting?
Yes, NCT07619560 is actively recruiting participants. Contact the research team at maggieh323@tmu.edu.tw for enrollment information.
Where is the NCT07619560 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07619560 clinical trial?
NCT07619560 is sponsored by Taipei Medical University. The trial plans to enroll 120 participants.
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