- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07625059
Stanford University Microbiome Bank (SUMB)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Roujheen Sabetan, MPH
- Telefonnummer: 650-498-8188
- E-post: rsabetan@stanford.edu
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94305
- Stanford University
-
Kontakt:
- Roujheen Sabetan, MPH
- Telefonnummer: 650-498-8188
- E-post: rsabetan@stanford.edu
-
Huvudutredare:
- Sean Spencer, MD, PHD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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 exclusion criteria
-Inability to comply with research requirements
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Healthy Donors
This group consists of healthy stool donors.
|
This is an observational study with no interventions.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Donor Eligibility Rate
Tidsram: During screening period
|
Proportion of screened individuals who meet eligibility criteria for stool donation
|
During screening period
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Microbiome Diversity of Donors
Tidsram: Baseline and every 60 days through study completion, up to 12 months
|
Alpha diversity (e.g., Shannon index) of stool samples from eligible donors
|
Baseline and every 60 days through study completion, up to 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sean Spencer, MD, PhD, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IRB 85544
Plan för individuella deltagardata (IPD)
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