Summary

Location
at UCSD
Dates
study started
estimated completion

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

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
American Gastroenterological Association
ID
NCT03325855
Study Type
Observational [Patient Registry]
Last Updated