Stanford University
Palo Alto, California, 94305, United States
Location contact
Roujheen Sabetan, MPH
CONTACT
Sean Spencer, MD, PHD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07625059
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Palo Alto, California, 94305, United States
Roujheen Sabetan, MPH
CONTACT
Sean Spencer, MD, PHD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior/concomitant therapy
Other exclusion criteria
-Inability to comply with research requirements
This is an observational study with no interventions.
Time frame: During screening period
Proportion of screened individuals who meet eligibility criteria for stool donation
Time frame: Baseline and every 60 days through study completion, up to 12 months
Alpha diversity (e.g., Shannon index) of stool samples from eligible donors
Contact information is provided by the study sponsor or research team.
Sean Spencer
Other
Acronym: SUMB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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