Healthy Adult ParticipantsSUMBNCT07625059
Stanford University Microbiome Bank
An observational study of Healthy Adult Participants, run by Sean Spencer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Microbiome bank
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Aug 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible participants will be at least 18-years of age, generally healthy, and living in the San Francisco Bay Area.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94305
Roujheen Sabetan, MPH, 650-498-8188, rsabetan@stanford.edu
Sean Spencer, MD, PHD
About this study
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.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- Microbiome bank
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome bankOther
This is an observational study with no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Donors | This group consists of healthy stool donors. Receives: Other: Microbiome bank |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor Eligibility Rate
Proportion of screened individuals who meet eligibility criteria for stool donation
Measured: During screening period
Secondary outcomes (1)
Microbiome Diversity of Donors
Alpha diversity (e.g., Shannon index) of stool samples from eligible donors
Measured: Baseline and every 60 days through study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sean Spencer
- Sponsor type
- University, hospital or other
- Collaborators
- Kepner Microbiome Fund, Mischa Deeter Research Fund, GI Diseases Fund
- Responsible party
- Sponsor-investigator, Sean Spencer, Stanford University
- Investigators
- Sean Spencer, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625059
- Sponsor's protocol ID
- IRB 85544
- Acronym
- SUMB
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford University Microbiome Bank
- ClinicalTrials.gov ID
- NCT07625059
- Acronym / sponsor ID
- SUMB / IRB 85544
- Conditions
- Healthy Adult Participants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sean SpencerUniversity, hospital or other
- Collaborators
- Kepner Microbiome Fund, Mischa Deeter Research Fund, GI Diseases Fund
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Donors | – | Other: Microbiome bankThis group consists of healthy stool donors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be at least 18-years of age, generally healthy, and living in the San Francisco Bay Area.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome bankThis is an observational study with no interventions. | Other | Healthy Donors |
Primary outcome
Donor Eligibility Rate
Time frame: During screening period
Proportion of screened individuals who meet eligibility criteria for stool donation
1 secondary outcome
Microbiome Diversity of Donors
Time frame: Baseline and every 60 days through study completion, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Adult Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingObservational study
Magnetic Field Maps With NV Application Kit MCG
Technical Feasibility and Performance of the Sensor System, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Spencer, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult Participants, run by Sean Spencer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roujheen Sabetan, MPH (650-498-8188, rsabetan@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor Eligibility Rate (time frame: During screening period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.