Stanford University Microbiome Bank

NCT07625059 | Not Yet Recruiting

• 1 other identifier: IRB 85544
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (1)

• Donor Eligibility Rate

  Proportion of screened individuals who meet eligibility criteria for stool donation

  During screening period

Secondary Outcomes (1)

• Microbiome Diversity of Donors

  Baseline and every 60 days through study completion, up to 12 months

Study Arms (1)

Healthy Donors

This group consists of healthy stool donors.

Other: Microbiome bank

Interventions

Microbiome bank OTHER

This is an observational study with no interventions.

Healthy Donors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be at least 18-years of age, generally healthy, and living in the San Francisco Bay Area.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sean Spencer: lead
• Kepner Microbiome Fund: collaborator
• GI Diseases Fund: collaborator
• Mischa Deeter Research Fund: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will retain stool, blood, saliva, and small intestinal fluid samples.

Study Officials

• Sean Spencer, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roujheen Sabetan, MPH

CONTACT

650-498-8188; rsabetan@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Medical Director of Microbiome Diagnostics and Therapeutics

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)