New donor screening protocols for clinical trials involving fecal microbiota transplantation


Again in Could, I wrote a weblog put up about fecal microbiota transplantation (FMT), or stool transplantation. FMT is taken into account standard-of-care remedy to deal with recurrent Clostridium difficile (C. diff) infections. On this process, stool from a wholesome donor is positioned into the intestine of a affected person, normally by way of colonoscopy, to revive useful micro organism that assist defend in opposition to recurrent C. diff an infection (rCDI).

An vital occasion occurred after my preliminary put up. On June 13, 2019, the FDA issued a security alert regarding the danger of transmission of multi-drug resistant organisms (MDRO) by way of FMT. MDROs are micro organism which can be immune to a number of antibiotics.

Security alert leaves many questions unanswered

The security alert was issued in response to the transmission of a selected MDRO from donor stool into two sufferers following FMT. Tragically, certainly one of these people died. The FDA announcement offers only a few particulars relating to these circumstances, and it doesn’t present data on the reason for this affected person’s dying. What is understood is that these two sufferers got FMT as a part of a analysis protocol and never as a part of medical care to deal with rCDI.

As I discussed in my earlier put up, FMT is supported by pointers, however remains to be thought of investigational and isn’t at the moment FDA-approved. FMT could be carried out for medical care to deal with rCDI. However an FMT for some other indication can solely be carried out within the setting of a medical trial.

The FDA has not but disclosed the indication or motive for the FMT for the 2 sufferers talked about of their security alert, however the FDA did word that the sufferers have been immunocompromised. FMT has been proven to be protected in immunocompromised sufferers, however typically these sufferers are at elevated danger for infections. Moreover, it was famous that the donor materials used on this analysis protocol had not been screened for MDROs.

FDA institutes new screening requirement for donor stool

Following this occasion, the FDA now requires MDRO screening for donor stool for all energetic and future FMT examine protocols. Worldwide, screening is being really helpful for medical protocols as effectively, and that is anticipated to be supported by an upcoming guideline.

It is very important word that every one main stool banks within the US and all over the world had carried out screening protocols to detect MDROs and exclude potential donors who take a look at constructive effectively previous to this occasion. This consists of OpenBiome, a big, non-profit stool financial institution that’s broadly used within the US and has offered over 45,000 therapies.

Previous to this there had been no earlier transmissions of MDROs reported, highlighting that this process nonetheless stays very protected total. That being mentioned, this occasion highlights the necessity for adherence to standardized screening protocols, which is essential for affected person security.

The FDA has reached out to websites which have ongoing FMT protocols to make sure applicable screening procedures are being adopted. Any protocols not using applicable screening practices have been placed on maintain. The FDA has not launched any additional details about what number of protocols or websites have been affected by this step.

Observe me on Twitter @DrJessicaA

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