Fecal Microbiota Transplant National Registry
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Max Brondfield, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- To assess short-term and long-term safety of FMT and other gut-related-microbiota products10 years
The safety of FMT is currently the greatest concern related to its use, and characterizing the safety of FMT and subsequent gut-related-microbiota products is the primary goal of the Registry. Short-term adverse events relate primarily to the method of delivery (e.g. colonoscopy) and to acute infections or other AEs from the donor fecal material and should be readily definable and quantifiable.The human-to-human transfer of feces may be associated with long-term health risks to the recipient because the gut microbiota is composed of many components that have not been characterized and can change over time in ways that cannot be currently predicted. It is imperative to determine if FMT leads to unintended development of serious conditions due to the transfer of gut microbiota. In addition to infections, the possibility that gut microbiota associated with a disease phenotype will be transplanted and result in chronic disease in recipients must be assessed.