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
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.
Study Type
OBSERVATIONAL
Enrollment
4,000
None - Observational
Occurrence of treatment related Adverse Events
Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.
Time frame: over 10 Years
Disease Re-occurrence Following FMT
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
Time frame: over 10 Years
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Phoenix Children's Hospital
Phoenix, Arizona, United States
WITHDRAWNChildren's Hospital of Los Angeles
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California
Los Angeles, California, United States
WITHDRAWNStanford University
Redwood City, California, United States
RECRUITINGSutter Roseville Medical Center
Roseville, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGVentura Clinical Trials
Ventura, California, United States
WITHDRAWNYale New Haven Hospital
Hamden, Connecticut, United States
RECRUITINGMedStar Georgetown University Hospital
Georgetown, District of Columbia, United States
ACTIVE_NOT_RECRUITINGBest Quality Research, Inc.
Hialeah, Florida, United States
WITHDRAWN...and 43 more locations