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

Официальное название

Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage Parkinson's Disease Patient

Обзор

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.

Вмешательства

• Пищевая добавка Y7
  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).
• Пищевая добавка Placebo
  Take two servings of the placebo product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks.

Первичные конечные точки

• Assessment of Questionnaire-Based Changes in Motor and Non-Motor Symptoms in Parkinson's Disease [Срок оценки: The baseline assessments were conducted two weeks prior to the intervention, and the post-intervention assessments were completed two weeks after the intervention.]

Вторичные конечные точки (12)

• Change from Baseline to Week 12 in Montreal Cognitive Assessment Score in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Mini-Mental State Examination Score in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Non-Motor Symptoms Scale Score in Patients with Parkinson's Disease [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Patient Assessment of Constipation Symptoms Score in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Bristol Stool Scale Score in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Mini Nutritional Assessment Score in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Body Composition Parameters in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Dietary Intake Based on 24-Hour Dietary Recall in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Gut Microbiota Composition in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]
• Change from Baseline to Week 12 in Fecal Short-Chain Fatty Acid Levels in Patients with Parkinson's Disease [Срок оценки: Baseline and Week 12 after intervention.]

Критерии участия

Критерии включения

Subject Inclusion Criteria:

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• Taipei Medical University Hospital — Taipei

Идентификаторы

NCT: NCT07619560 · N202405094

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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