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| Name | Class |
|---|---|
| Kepner Microbiome Fund | UNKNOWN |
| Mischa Deeter Research Fund | UNKNOWN |
| GI Diseases Fund | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Donors | This group consists of healthy stool donors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiome bank | Other | This is an observational study with no interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Donor Eligibility Rate | Proportion of screened individuals who meet eligibility criteria for stool donation | During screening period |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome Diversity of Donors | Alpha diversity (e.g., Shannon index) of stool samples from eligible donors | Baseline and every 60 days through study completion, up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Prior/concomitant therapy
Other exclusion criteria
-Inability to comply with research requirements
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Eligible participants will be at least 18-years of age, generally healthy, and living in the San Francisco Bay Area.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roujheen Sabetan, MPH | Contact | 650-498-8188 | rsabetan@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sean Spencer, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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We will retain stool, blood, saliva, and small intestinal fluid samples.