Stanford University Microbiome Bank

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Microbiome bank
  This is an observational study with no interventions.

Первичные конечные точки

• Donor Eligibility Rate [Срок оценки: During screening period]

Вторичные конечные точки (1)

• Microbiome Diversity of Donors [Срок оценки: Baseline and every 60 days through study completion, up to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Stanford University — Palo Alto

Идентификаторы

NCT: NCT07625059 · IRB 85544

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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