Stanford University Microbiome Bank
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This protocol establishes a centralized stool donor bank and research platform to support microbiota transplantation therapy (MTT) for microbiota-mediated diseases. The study will characterize donor microbiome, metabolite, immune, and dietary profiles.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究者
Sean Spencer
Assistant Professor of Medicine and Medical Director of Microbiome Diagnostics and Therapeutics
Stanford University