Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Najwa El-Nachef, MD

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 San Francisco not yet accepting patients
    San Francisco California 94115 United States
  • Stanford University accepting new patients
    Redwood City California 94063 United States

Lead Scientist at UCSF

  • Najwa El-Nachef, MD
    Associate Professor, Medicine, School of Medicine. Authored (or co-authored) 19 research publications. Research interests: Fecal Microbiota Transplant · Intestinal Microbiome · Celiac Disease · Inflammatory Bowel Disease · Balloon Assisted Enteroscopy

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