Fecal Microbiota Transplant National Registry
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Clostridium Difficile Infection
- Fecal Microbiota Transplantation
- Gut Microbiome
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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 inform...
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.
Tracking Information
- NCT #
- NCT03325855
- Collaborators
- OpenBiome
- University of California, San Diego
- Icahn School of Medicine at Mount Sinai
- Investigators
- Principal Investigator: Gary D Wu, MD Co-Director, PennCHOP Microbiome Program Principal Investigator: Colleen Kelly, MD Brown University Principal Investigator: Loren Laine, MD Yale School of Medicine
Get Well Soon