Summary

Location
at UCLA UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Otto Yang, M.D. (ucla)Max Brondfield, MD (ucsf)
Headshot of Otto Yang
Otto Yang
Headshot of Max Brondfield
Max Brondfield

Description

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

Details

This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.

Keywords

Fecal Microbiota Transplantation, Clostridium Difficile Infection, Gut Microbiome, FMT, CDI, Fecal Matter Transplant, Clostridium Infections

Eligibility

You can join if…

  • Recipient Inclusion Criteria
    • 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
  • Donor Inclusion
    • Ability to give informed consent
    • Providing stool sample for FMT

You CAN'T join if...

  • Incarceration

Locations

  • University of California not yet accepting patients
    Los Angeles California 90095 United States
  • University of California San Francisco not yet accepting patients
    San Francisco California 94115 United States
  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Stanford University accepting new patients
    Redwood City California 94063 United States

Lead Scientists at University of California Health

  • Otto Yang, M.D. (ucla)
    Professor, Medicine. Authored (or co-authored) 191 research publications
  • Max Brondfield, MD (ucsf)
    Dr. Max Brondfield is an assistant professor in the division of gastroenterology at UCSF in San Francisco. He completed his medical degree, internal medicine residency, chief residency, and fellowship at UCSF. His include celiac disease, functional GI disorders including irritable bowel syndrome, fecal microbiota transplantation, and inflammatory bowel disease.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
American Gastroenterological Association
ID
NCT03325855
Study Type
Observational [Patient Registry]
Participants
Expecting 4000 study participants
Last Updated