Healthy Adult Participants
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMicrobiome bank
This is an observational study with no interventions.
Sponsors
Sean Spencer
Kepner Microbiome Fund
Mischa Deeter Research Fund
GI Diseases Fund
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor Eligibility Rate | During screening period | Proportion of screened individuals who meet eligibility criteria for stool donation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome Diversity of Donors | Baseline and every 60 days through study completion, up to 12 months | Alpha diversity (e.g., Shannon index) of stool samples from eligible donors |
Countries
United States
Contacts
CONTACTRoujheen Sabetan, MPH
PRINCIPAL_INVESTIGATORSean Spencer, MD, PhD
Stanford University
Outcome results
None listed