May 31st, 2013

Fecal Microbiota Transplantation — Try This At Home?

As noted before, the FDA says that an investigational new drug (IND) application is required for therapeutic use of fecal microbiota transplantation.

The practical effect of this decision, at least at our institution, is to stop providing this service — it’s on hold pending those “internal discussions” planned by the FDA on the regulatory issues surrounding the procedure.

Which is why reading this anecdote from Mike Edmond, an ID doctor in Virginia, came as no surprise:

I was scheduled to perform a fecal transplant on a patient this morning, but notified her a few weeks ago that we could not proceed because of the new ruling. She presented to clinic this morning and informed me that she had performed the transplant at home a few days ago. And she was happy to report that she was feeling much better!  As it turns out, I have at least 3 more patients in the process of preparing for self-administered fecal transplant at home.

He goes on to say that instructions for doing it home “are readily available on the internet,” which I’m sure is true but am too squeamish right now to check.

(OK, I did it — here is a comprehensive and detailed guide.)

(Fooled you.)

So here’s the irony: FDA’s decision to require an IND will undoubtedly drive quite a bit of FMT into peoples’ homes — where it is completely unregulated. Sigh, unintended consequences are so annoying …

Note that some clinical sites have in fact an IND from the FDA to continue FMT, so it’s worth checking around your local hospitals.

And for those of you who didn’t click the above link, here it is:

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HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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