SK Hourigan et al. JPGN 2021; 73: 430-432. Updates and Challenges in Fecal Microbiota Transplantation for Clostridioides difficile Infection in Children
This good update provides a lot of useful information regarding fecal microbiota transplantation (FMT) and a word of caution regarding its future availability.
Key points regarding FMT:
- Long-term safety remains unknown. FMT may lead to susceptibility to chronic inflammatory, allergic, and autoimmune diseases. “FMT has been associated with durable transmission of pro-carcinogenic bacteria from adult donors to pediatric recipients…although the long-term consequences…are unknown.”
- Due to transfer of extended spectrum beta-lactamase (ESBL) E coli to 2 immunocompromised adult recipients, further screening of FMT was implemented.
- Though there is no published evidence of SARS-CoV-2 fecal transmission, the FDA “advised additional precautions and testing in March 2020; “however, there are no molecular tests with stool…which have received emergency use authorization.” Hence, most FMT programs were on hold as of January 2021.
- After 2021, OpenBiome, whose product was recently available again, is expected to stop distribution of FMT donor product due to increased costs of screening and the “promising biotherapeutics” that are in phase III trials.
- Biotherapeutic is “loosely defined as drug therapy products where the active substance is extracted from a biological specimen.” The new products are likely to have “increased standardization, safety and practicality.”
- The problem in pediatrics: none of these biotherapeutic products have started trials in children. This will lead to treatment problems. Even if one wanted to set up donor-directed FMT, it will be difficult to complete all of the screening recommended by the FDA. It could lead to self-administration by families with uncertain risks.
My take: My first reaction to this article: ‘Oh crap!’ It is sad and ironic that I will miss having available commercial stool for FMT.
Related blog posts:
- More Details on Drug-Resistant E coli Transmitted by Fecal Microbiota Transplant | gutsandgrowth
- Fecal Microbial Transplantation -Evidence for Use Beyond Recurrent Clostridium Difficile | gutsandgrowth
- NY Times: “Should We Bank Our Own Stool?”
- Clostridium difficile/Fecal Microbiota Transplantation Video
- OpenBiome -Nation’s 1st Human Stool Bank | gutsandgrowth
- Fecal Transplantation: “Frozen is as Good as Fresh” | gutsandgrowth
- Consensus Guidelines on FMT | gutsandgrowth -includes link to AGA website which has a terrific patient brochure and other patient educational materials.