- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07625059
Stanford University Microbiome Bank (SUMB)
연구 개요
상세 설명
Eligible participants will undergo comprehensive baseline screening including physical examination, infectious disease testing, and health history assessment. Those who qualify will enter an active donation period of up to 12 months, during which they will provide stool samples at a frequency ranging from once per month to once per week, depending on their availability.
In addition to stool collection, participants will provide biospecimens including blood draws (for infectious disease and metabolic monitoring), saliva samples, and small intestinal fluid samples collected using an ingestible capsule device (CapScan). The CapScan capsule is swallowed by the participant, collects intestinal fluid as it passes through the small intestine, and is retrieved from stool and returned to the research team for analysis.
This biobank will serve as infrastructure for ongoing microbiome research, providing rigorously screened and comprehensively characterized biospecimens to advance understanding of the gut microbiome's role in health and disease, and to support development of safe and effective microbiota-based therapies.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Roujheen Sabetan, MPH
- 전화번호: 650-498-8188
- 이메일: rsabetan@stanford.edu
연구 장소
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California
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Palo Alto, California, 미국, 94305
- Stanford University
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연락하다:
- Roujheen Sabetan, MPH
- 전화번호: 650-498-8188
- 이메일: rsabetan@stanford.edu
-
수석 연구원:
- Sean Spencer, MD, PHD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any person aged 18-80 years of age, inclusive at the time of signing the consent
- In good general health as evidenced by medical history
- Ability to travel to donation facility on a weekly basis
- Residence within 5 miles of Stanford Campus
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- Capable of providing signed informed consent.
Exclusion Criteria:
- Inflammatory bowel disease
- Enteric infections
- Previous infection with Clostridium difficile
- History of gastrointestinal surgery: Participants with gastrointestinal surgeries below the pylorus will be excluded from this protocol, including participants with a history of colectomy, segmental colonic resection, and small bowel resections.
- Documented severe gastroparesis
- Active intestinal obstruction
- Dysphagia (oropharyngeal, esophageal, functional or neuromuscular)
- History or current malignancy diagnosis
- History of recurrent aspiration episodes
- Any conditions associated with a high risk of bleeding, including but not limited to coagulopathy/bleeding disorder, severe liver disease, active or recent GI bleeding, or recent abdominal or other GI surgery
- Active diagnosis of major depressive disorder
- Active diagnosis of major anxiety disorder
- Severe immunodeficiency, inherited or acquired (e.g., Human immunodeficiency virus, active chemotherapy or immunosuppressive medications [including steroids, biologic therapy, or bone marrow suppressive agents], or radiation therapy)
- BMI of less than 18 or BMI greater than 30
- Record of eating disorders
- Active use of GLP-1 inhibitors
- Diagnosis of Human immunodeficiency virus infection; Hepatitis A, B, C & E; Epstein Bar Virus; parasitic infections; Syphilis
- Pregnancy & lactation
- Active drug, or alcohol use disorder
- Tobacco, marijuana and e-cigarette use
- Any other significant medical condition that could confound or interfere with evaluation of safety or tolerability or prevent compliance with the study protocol at the discretion of the Investigator
Prior/concomitant therapy
- Active antibiotic use
- Active treatment with high levels of immunosuppressive therapies (active chemotherapy or immunosuppressive medications [including steroids, biologic therapy, or bone marrow suppressive agent], or radiation therapy)
- Simultaneous participation in another interventional clinical trial
Other exclusion criteria
-Inability to comply with research requirements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Healthy Donors
This group consists of healthy stool donors.
|
This is an observational study with no interventions.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Donor Eligibility Rate
기간: During screening period
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Proportion of screened individuals who meet eligibility criteria for stool donation
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During screening period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Microbiome Diversity of Donors
기간: Baseline and every 60 days through study completion, up to 12 months
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Alpha diversity (e.g., Shannon index) of stool samples from eligible donors
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Baseline and every 60 days through study completion, up to 12 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Sean Spencer, MD, PhD, Stanford University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB 85544
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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