Fecal Microbiota Transplant National Registry

NCT06262451 | Enrolling By Invitation

• 2 other identifiers: 20-301825R24AI118629
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits.

Conditions

Fecal Microbiota Transplant

Keywords

FMT

Outcome Measures

Primary Outcomes (1)

• To assess short-term and long-term safety of FMT and other gut-related-microbiota products

  The safety of FMT is currently the greatest concern related to its use, and characterizing the safety of FMT and subsequent gut-related-microbiota products is the primary goal of the Registry. Short-term adverse events relate primarily to the method of delivery (e.g. colonoscopy) and to acute infections or other AEs from the donor fecal material and should be readily definable and quantifiable.The human-to-human transfer of feces may be associated with long-term health risks to the recipient because the gut microbiota is composed of many components that have not been characterized and can change over time in ways that cannot be currently predicted. It is imperative to determine if FMT leads to unintended development of serious conditions due to the transfer of gut microbiota. In addition to infections, the possibility that gut microbiota associated with a disease phenotype will be transplanted and result in chronic disease in recipients must be assessed.

  10 years

Secondary Outcomes (4)

• To characterize effectiveness of FMT and other gut-related-microbiota products.

  10 years

• To gather information on FMT practice in North America

  10 years

• To promote scientific investigation.

  10 years

• To aid practitioners and sponsors in satisfying regulatory requirements

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be eligible for participation regardless of age, race, ethnicity, or gender. Pediatric patients may participate if consent is given by a guardian.

You may qualify if:

• Ability to give informed consent
• Receiving FMT or other gut-related microbiota product within 90 days after providing consent
• Access to internet and/or telephone
• Ability to give informed consent
• Providing stool sample for FMT

You may not qualify if:

• Incarceration

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Study Officials

• Max Brondfield, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: October 20, 2023
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)