Fecal Microbiota Transplantation in Parkinson's Disease. (FMT)
2026년 5월 13일 업데이트: Chang Gung Memorial Hospital
Fecal Microbiota Transplantation for the Treatment of Patients With Parkinson's Disease.
Fecal microbiota transplantation (FMT) is an effective and safe treatment for Clostridioides difficile infection (CDI).
Though CDI is the only indication for FMT, more and more preliminary data on FMT in neurological disorders are reported due to gut-brain axis.
This study is a pilot study to apply FMT on patients with Parkinson's disease (PD).
The effect of FMT on motor and non-motor symptoms in PD will be also evaluated.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
- Screening and Enrollment Participants will be recruited from movement disorders clinics at Chang Gung Memorial Hospital (CGMH). Written informed consent will be obtained prior to study participation. Control group participants will undergo the same evaluation protocol as the treatment group, except for fecal microbiota transplantation (FMT).
Clinical Assessments Before the baseline visit, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed.
Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT.
Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months.
Donor Screening and Specimen Processing Healthy donors will undergo comprehensive screening, including medical history, risk assessment, and laboratory testing, in accordance with national FMT consensus guidelines. Eligible donors will provide stool samples under standardized conditions.
Samples will be processed at the CGMH microbiota center following established protocols, including preparation for microbiome and metabolite analyses (e.g., short-chain fatty acids) using validated laboratory methods such as gas chromatography-mass spectrometry (GC-MS). Blood samples from participants will also be collected and stored for analysis.
Clinical Outcome Measures
Assessments will include:
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS, on/off medication) Hoehn and Yahr stage Levodopa equivalent daily dose (LEDD) Motor complications (3-day diary) Montreal Cognitive Assessment (MoCA)
Patient-reported outcomes:
Wearing-Off Questionnaire (WOQ-9) Parkinson's Disease Questionnaire (PDQ-39) SENS-PD (non-dopaminergic symptoms) Parkinson's Disease Constipation Questionnaire (PDCQ)
- FMT Procedure Participants in the treatment group will receive oral vancomycin (125 mg every 6 hours for 3 days) and follow a low-fiber diet prior to FMT. After bowel preparation and a 24-hour washout period, processed donor microbiota will be delivered to the terminal ileum or cecum via ileocolonoscopy. Participants will remain in the right lateral position for at least 30 minutes post-procedure.
- Specimen Storage All collected specimens will be stored at -80°C at the microbiota center until study completion. Residual samples will be transferred to the institutional biobank or destroyed according to participant consent.
- Transportation Microbiota preparations will be transported under controlled temperature conditions. For intra-hospital use, samples will be delivered immediately with cold-chain protection. For inter-hospital transport, samples will be frozen at -80°C, shipped on dry ice, and used on the day of arrival or stored for up to 180 days.
- Quality Control and Follow-up All procedures, including donor selection, sample processing, and patient care, will follow national FMT consensus guidelines. Participants will be monitored at scheduled follow-ups (1 week, 3 months, and 6 months), with additional assessments arranged as needed to ensure safety and data completeness.
연구 유형
중재적
등록 (추정된)
58
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Siao-Chu Su, Bachelor
- 전화번호: +886978835982
- 이메일: b9805039@cgmh.org.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:
- Clinical diagnosis of idiopathic PD according to UK brain bank criteria.
- PD disease duration ≧5 years to avoid the possible misdiagnosis of atypical parkinsonism.
- Hoehn-Yahr stage 1-4
- Using levodopa in a currently fixed dose.
- Presence of motor complications (motor fluctuation or dyskinesia).
- Written informed consent.
- Age above 18.
Exclusion Criteria:
- Hoehn-Yahr stage 5. (wheelchair ridden or bedridden due to PD)
- Dementia (MMSE<24), history of encephalitis, or brain organic lesions, including congenital or acquired structural abnormalities (which were detected through brain computed tomography scan or Magnetic Resonance Imaging) may affect neurological function, leading to various neurological deficits and mpairing the cognitive function.
- Current use of probiotics or in the past 3 months.
- For women with childbearing potential. (Female participants are suggested to prevent pregnancy during this trial and undergo a pregnancy test before enrollment.)
- Current need of antibiotics or use in the previous 3 months.
- End stage renal disease caused uremic encephalopathy or liver cirrhosis caused hepatic encephalopathy
- Immunocompromised state.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Experimental Group
In the experimental group, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed. Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT. Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months. |
All subjects in the treatment group will receive FMT once.
Recipients must adhere to a low-fiber diet for three days, and pre-treatment antibiotics with Vancomycin 125 mg, administered as 2 capsules every 6 hours for 3 days.
After a 24-hour washout period, they underwent colon preparation followed by FMT.
During the procedure, processed 250cc microbiota fluid from healthy donors, provided by the Chang Gung fecal bank, was administered into the terminal ileum or cecum via ileocolonoscopy.
To ensure safety and traceability, only a single-donor microbiota is used.
After FMT, patients were instructed to lie on their right side for at least 30 minutes.
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활성 비교기: Control Group
In the control group, all the assessments will be conducted at the baseline, 3 months, and 6 months.
Stool samples will be collected at baseline, 3 months, and 6 months.
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All subjects in the Control group will not receive FMT.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary endpoint
기간: 6 months
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The improvement of the motor section scores of MDS-UPDRS in an off- medication state, from baseline to 6 months post-FMT for the treatment group compared to the control group.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary endpoints
기간: 6 months
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The change of levodopa-equivalent daily dose (LEDD) and non-motor symptoms of patients with PD after FMT.
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chiung-Chu Chen, PhD., Chang Gung Memorial Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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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 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2029년 4월 7일
연구 완료 (추정된)
2029년 4월 7일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 13일
마지막으로 확인됨
2026년 4월 1일
추가 정보
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