Flora Medicine’s Response to the FDA Alert Regarding Fecal Transplant

On June 13, 2019 the Food and Drug Administration (FDA) reported that two immunocompromised individuals contracted a multi-drug resistant organism (MDRO) from the same donor after seeking fecal microbiota transplant (FMT) through a clinical trial. One of these individuals, subsequently died. The organism was extended-spectrum beta-lactamase (ESBL) producing Escherichia coli (E.coli).

Why wasn’t this organism screened for?

The first published recommendations for FMT donor screening in the United States were made in 2011 by Bakken et al. as part of a joint expert committee. This was mostly based on screening guidance for other blood and tissue donations. A recommendation to include screening for ESBL was not included in this publication or in any FDA guidance. Since then, published recommendations from large medical organizations and experts have evolved. The most comprehensive recent summary by Woodworth et al. in 2017 didn’t list ESBL, but other antibiotic resistant pathogens including MRSA in a secondary category of additional screening to “possibly consider”.

What does immunocompromised mean?

An immunocompromised person has a weakened immune system. Individuals with AIDS, cancer, diabetes, malnutrition and some genetic disorders are considered immunocompromised. Additionally, individuals on prescription medications or specific treatment regimens such as anticancer drugs, radiation therapy and stem cell or organ transplant are considered immunocompromised. These individuals receive this designation due to their immune system’s inability to fight infection or other diseases because of their inability to mount an immune response.

Should immunocompromised be treated with FMT?

A recent review by Wardill et al. stated that FMT treatment in immunocompromised patients has vast potential to treat a variety of life-threatening conditions including MDROs like ESBL. These patients are at higher risk for death from many infections and complications that would not be as dangerous for other populations. The review paper also discusses the very real dangers associated with all treatment in this high-risk population.

Is FMT OK to pursue for recurrent Clostridium difficile?

Yes. Fecal transplant, when supplied by a stool bank rigorously screening their donors, can be an incredibly safe and effective tool for treating Clostridium difficile (C.diff) infections. A recent study by Millan et al. showed C.diffpatients had an increased level of antibiotic resistant (ABR) genes from various bacterial species when compared to healthy controls. In this same study, the use of FMT significantly reduced the presence of those species and ABR genes in addition to resolving their C.diff infections.

What does this alert mean?

The FDA is communicating that these therapies are not without risk. As with all medical intervention, therapies carry inherent danger. It is the job of the FDA to take the most conservative and cautious approach with any new therapy. This alert provides increased awareness regarding the importance of donor screening in order to continue providing this life saving therapy.

Here at Flora Medicine, we recognize and communicate these risks to all our patients and clients. We do our best to mitigate those risks by rigorously screening our donors via intensive interviews, physical exams and extensive laboratory analysis of both blood and stool. In this process, we ask questions regarding recent and past hospitalizations, family history, and exposures. Risk mitigation is our job and it’s one we take very seriously. We will continue to follow the FDA guidelines for safe practices for stool donor screening.

If you have any questions or concerns regarding this recent statement, please reach out to us at Info@FloraMedicine.com. We are happy to answer any questions you may have.