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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

2026년 5월 24일 업데이트: Huang, Hui-Yu, Taipei Medical University

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

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대만
      • Taipei, 대만, 110
        • 모병
        • Taipei Medical University Hospital
        • 연락하다:
          • Taipei Medical University Hospital
          • 전화번호: +886 +2 27372181
          • 이메일: ihc@h.tmu.edu.tw

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Parkinson Disease Probiotic product intervention group (Y)
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.
건강 보조 식품: 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).
위약 비교기: Parkinson Disease group (P)
P group must conform to inclusion criteria and exclusion criteria. P group need to finish pre test and post test.
건강 보조 식품: Placebo
Take two servings of the placebo product daily: one serving after breakfast and one serving after dinner, for a duration of 12 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Assessment of Questionnaire-Based Changes in Motor and Non-Motor Symptoms in Parkinson's Disease
기간: The baseline assessments were conducted two weeks prior to the intervention, and the post-intervention assessments were completed two weeks after the intervention.
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.

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline to Week 12 in Montreal Cognitive Assessment Score in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
The Montreal Cognitive Assessment is used to evaluate cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. A score below 26 suggests possible cognitive impairment.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Mini-Mental State Examination Score in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
The Mini-Mental State Examination is used to assess global cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance and lower scores indicating greater cognitive impairment.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Non-Motor Symptoms Scale Score in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
The Non-Motor Symptoms Scale is used to assess the frequency and severity of non-motor symptoms in patients with Parkinson's disease. Higher scores indicate greater non-motor symptom burden and worse clinical condition.
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
기간: Baseline and Week 12 after intervention.
The Parkinson's Disease Questionnaire-39 is used to evaluate health-related quality of life in patients with Parkinson's disease. Scores are transformed to a 0 to 100 scale, with higher scores indicating poorer quality of life.
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
기간: Baseline and Week 12 after intervention.
The Parkinson's Disease Sleep Scale is used to evaluate sleep disturbances in patients with Parkinson's disease. The scale includes 15 items, each scored from 0 to 10. Higher scores indicate better sleep quality and fewer sleep-related symptoms.
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
기간: Baseline and Week 12 after intervention.
The Patient Assessment of Constipation Symptoms questionnaire is used to assess constipation-related gastrointestinal symptoms. Higher scores indicate more severe constipation symptoms and worse gastrointestinal status.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Bristol Stool Scale Score in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
The Bristol Stool Scale is used to classify stool form. Scores range from 1 to 7, with lower scores indicating harder stools and higher scores indicating looser stools. Scores around 3 to 4 generally indicate more normal stool form.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Mini Nutritional Assessment Score in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
The Mini Nutritional Assessment is used to evaluate nutritional status. Higher scores indicate better nutritional status, whereas lower scores indicate increased risk of malnutrition or poorer nutritional condition.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Body Composition Parameters in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Body composition will be assessed using InBody analysis. Parameters may include body weight, skeletal muscle mass, body fat mass, and body mass index. Each parameter will be reported separately using its corresponding unit of measurement.
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
기간: Baseline and Week 12 after intervention.
Dietary intake will be assessed using the 24-hour dietary recall method. Nutrient intake, including total energy, macronutrients, and selected nutrients, will be analyzed. Each dietary variable will be reported separately using its corresponding unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Gut Microbiota Composition in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Gut microbiota composition will be assessed using shotgun metagenomic sequencing of fecal samples. Changes in microbial diversity and relative abundance of bacterial taxa will be evaluated to explore gut microbiota alterations after intervention.
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
기간: Baseline and Week 12 after intervention.
Fecal short-chain fatty acids will be measured to evaluate changes in gut microbiota-derived metabolites after intervention. Each short-chain fatty acid will be reported separately using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Fecal Bile Acid Levels in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Fecal bile acids will be measured to evaluate changes in gut microbiota-related metabolic activity after intervention. Each bile acid will be reported separately using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Branched-Chain Amino Acid Levels in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Serum branched-chain amino acids, including valine, leucine, and isoleucine, will be measured to evaluate changes in amino acid metabolism after intervention. Each metabolite will be reported separately using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Tryptophan Level in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Serum tryptophan will be measured to evaluate changes in tryptophan metabolism after intervention. Tryptophan is an essential amino acid involved in serotonin, kynurenine, and indole-related metabolic pathways. Results will be reported using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Tyrosine Level in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Serum tyrosine will be measured to evaluate changes in amino acid metabolism after intervention. Tyrosine is related to catecholamine synthesis and may reflect metabolic alterations associated with Parkinson's disease. Results will be reported using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Serotonin Level in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Serum serotonin will be measured to evaluate changes in tryptophan-related metabolic pathways after intervention. Results will be reported using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Indole-3-Propionic Acid Level in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Serum indole-3-propionic acid will be measured to evaluate changes in gut microbiota-derived tryptophan metabolites after intervention. Results will be reported using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Serum Rab35 Level in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Serum Rab35 will be measured as an exploratory biomarker related to intracellular trafficking and protein processing. Results will be reported using its corresponding concentration unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in General Biochemical Blood Marker Levels in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
General biochemical blood markers, including AST, ALT, albumin, creatinine, BUN, uric acid, total cholesterol, triglycerides, HDL, LDL, HbA1c, glucose, insulin, total bilirubin, and ApoE, will be measured. Each marker will be reported separately using its corresponding unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Inflammatory Marker Levels in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Inflammatory markers, including tumor necrosis factor-alpha, transforming growth factor-beta, zonulin, neurofilament light chain, and calprotectin, will be measured to evaluate changes in systemic inflammation, gut barrier function, and neurodegeneration-related biomarkers. Each marker will be reported separately using its corresponding unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Antioxidant Marker Levels in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Antioxidant markers, including catalase, glutathione peroxidase, and superoxide dismutase, will be measured to evaluate changes in antioxidant defense status after intervention. Each marker will be reported separately using its corresponding unit.
Baseline and Week 12 after intervention.
Change from Baseline to Week 12 in Immune Cell Profiles Measured by Flow Cytometry in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
Immune cell profiles will be assessed using flow cytometry to evaluate changes in immune status after intervention. Each immune cell population will be reported separately as a percentage or absolute count, as appropriate.
Baseline and Week 12 after intervention.
Incidence of Adverse Events During the 12-Week Intervention Period in Patients with Parkinson's Disease
기간: From baseline to Week 12 after intervention.
Adverse events will be assessed throughout the intervention period to evaluate the safety and tolerability of the intervention. Events such as diarrhea, nausea, abdominal discomfort, or other self-reported symptoms will be recorded.
From baseline to Week 12 after intervention.
Change from Baseline to Week 12 in Clinical Global Impression Score in Patients with Parkinson's Disease
기간: Baseline and Week 12 after intervention.
The Clinical Global Impression scale will be used to evaluate overall clinical status and treatment response. Higher or lower scores will be interpreted according to the specific CGI subscale used in the study.
Baseline and Week 12 after intervention.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Taipei Medical University

협력자

Taipei Medical University Hospital
Taipei Medical University Shuang Ho Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 5월 20일

기본 완료 (추정된)

2027년 8월 31일

연구 완료 (추정된)

2027년 8월 31일

연구 등록 날짜

최초 제출

2026년 4월 9일

QC 기준을 충족하는 최초 제출

2026년 5월 24일

처음 게시됨 (실제)

2026년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 24일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • N202405094

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Data sharing may be considered on a case-by-case basis upon reasonable request and subject to a formal data use agreement.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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