Clostridium Difficile Infection, Fecal Microbiota Transplantation, Gut Microbiome
Conditions
Keywords
FMT, CDI, Fecal Matter Transplant
Brief 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
Detailed 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 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.
Interventions
OTHERNone - Observational
None - Observational
Sponsors
American Gastroenterological Association
OpenBiome
University of California, San Diego
University of Pennsylvania
University of Minnesota
Loyola University Chicago
Commure, Inc
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment related Adverse Events | over 10 Years | Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases. |
| Disease Re-occurrence Following FMT | over 10 Years | Assess effectiveness of FMT by monitoring disease re-occurrence post treatment. |
Countries
Canada, United States
Contacts
CONTACTSonya Serra, MSc
CONTACTLydia Fredell, MA
PRINCIPAL_INVESTIGATORGary D Wu, MD
Co-Director, PennCHOP Microbiome Program
PRINCIPAL_INVESTIGATORColleen Kelly, MD
Brigham and Women's Hospital
PRINCIPAL_INVESTIGATORLoren Laine, MD
Yale University
Outcome results
None listed