Just in time for #ASM2013 – FDA adding regulations for fecal transplants #microbiome

Well, I guess this could be good news or bad news or both.  The FDA has sniffed the winds of microbiome studies and decided that it wants some more regulation on fecal transplants (aka fecal bacteriotherapy).  See for example Fecal Transplant: FDA Wants Regulation.  Fecal transplants are spreading like crazy these days and every where I go in real life and online I hear and see more about them.   For more on fecal transplants see some of my previous posts such as More (you know you wanted it) on fecal transplants and the microbiome and Fecal transplants in the news and Transfaunation and Fecal Transplants: What Goes Around Comes Around, Literally and Figuratively.

I guess the FDA feels like they have to do something given the spread of FT.   Given how many scam artists and oversellers of the microbiome are out there I think some sort of increased protection or regulation is probably a good thing.  But I am not sure what the best way to do this is.  Clearly some are unhappy with the FDA sticking their noses into fecal transplants (e.g., see here).  But given how little we know about FTs other than as treatment for Clostridium dificile infections it seems like one could make a reasonable argument for more regulation or caution.  It seems strange though that we can do just about anything and everything we want to kill all the microbes around us with very little regulation and yet attempting to manipulate the microbes in and on us or add a few here and there is being regulated more.

What do others think?  Do we need more regulation from the FDA on fecal transplants?

UPDATE – some links to other discussions of this:

Must read microbiome paper of the month: defined microbioata treatment of Cdiff infections

This is a must read: PLOS Pathogens: Targeted Restoration of the Intestinal Microbiota with a Simple, Defined Bacteriotherapy Resolves Relapsing Clostridium difficile Disease in Mice

This is the paper I referred to in a previous post: Mouse study of fecal transplants to treat Cdiff infection.  This post was about a BBC News story that appeared to have jumped the embargo.  And then the news article disappeared and the scientific article was missing.  Thankfully the paper is now out.

The article has gotten some press that was not retracted.

More on fecal transplants and bacteriotherapy from my blog can be found below:

Overselling the microbiome award of the month: Integrative medical group of Irvine

Wow.  Just discovered this site: Fecal Transplantation | Integrative Medical Group of Irvine.  Not sure how long it has been out there.  But this is one of the more aggressive and perhaps egregious overselling of the power of the human microbiome that I have seen. They are promoting fecal transplants at their clinic as a way to cure a diverse array of ailments from ulcerative colitis to obesity and imply they can be used for cardiovascular health, emotional status, bone health, and more.  My “favorite” part:

As our understanding of the enormous importance of bowel micro-biota (bacteria) grows, the indications for fecal transplant will expand greatly and public acceptance will follow. But there is no reason for you to wait. Dr. Lee, our naturopathic doctor, is one of only a tiny handful of specialists certified in the use of fecal transplant. She can expertly manage your case.

Yes that is right.  We (the royal We of course) are on the verge of showing that the microbiota does EVERYTHING and therefore, if anything ails you, just wash your troubles away with some shit from a relative.  There is no reason to wait.  Come in to our clinic now.

And for the misleading nature of this site, I am giving this Integrative Medical Group of Irvine my coveted “Overselling the microbiome award.”  Previous winners and discussions of this issue are listed below:

Mouse study of fecal transplants to treat Cdiff infection

Interesting story in thge BBC News on a paper from PLoS Pathogens: BBC News – Faecal transplant clue to treating gut bug (seems that the article has disappeared – maybe they jumped the Embargo? — anyone — found another version here). In the work, researchers from the Sanger Institute infected mice with Clostridium difficile and then treated them with different combinations of microbes isolated from mouse feces. In the end they are reported to have identified a combination of six strains that was highly effective in clearing the C. difficile infections. I say “reported to have …” because I cannot find the PLoS Pathogens paper, again suggesting to me that the BBC story may have somehow jumped the embargo. Will post more when more comes out.

Fecal transplants in the news

CNN has a story on a fecal transplant case: Little-known fecal transplant cures woman’s bacterial infection – CNN.com.  It is worth a look and if you want to laugh (sometimes in pain, sometimes for jokes) read the comments. Some other recent stories on this topic include

And the CNN story got picked up by Reddit
As many know – I have been talking / writing about such treatments a bit recently.  I discussed it in my Tedmed talk (which is now on Ted).

http://video.ted.com/assets/player/swf/EmbedPlayer.swf And I have a blog post with background and links on the topic.

Got poo?: Clinical trial on fecal transplants (aka fecal bacteriotherapy) to treat C. difficile infections

Normally I avoid covering press releases here on my blog but this one is actually worth noting: Groundbreaking Clinical Trial Looks at Fecal Transplant as Treatment for C. Difficile | Women’s Medicine Collaborative.  It details the funding of a clinical trial to study the effectiveness of fecal transplants in treating Clostridium difficile infections.

Fecal transplants have gotten a growing amount of publicity over the last few years.  And they certainly seem to have potential.  But though they have been shown to be safe, they have not yet been shown in a clinical trial to be effective in treating anything.  So it is good to see a funded clinical trial on such transplants (though I note, transplant is probably the wrong word to use – maybe fecal bacteriotherapy is more appropriate.

For some background on fecal transplants see

Episode of Radio New Zealand "This Way Up": "Meet your microbes" discussion w/ me

Did an interview over the phone with Simon Morton for Radio New Zealand’s “This Way Up.”  Discussing microbial diversity and in part as a follow up on my TEDMED/TED talk.

Transfaunation and Fecal Transplants: What Goes Around Comes Around, Literally and Figuratively

In 2006 when I had just moved to UC Davis from TIGR, I was on a Southwest flight from Sacramento to (I think) Arizona. The person sitting next to me and I did the normal chit chat – what do you do? where are you going? etc. And the conversation became fascinating. The person sitting next to me was Mike Lagrone – a farrier (I forget people’s names frequently ten minutes after meeting them – but his name I remember even today, so he clearly made an impression). He travelled around the West helping take care of people’s horses. (I note – I think more information about him is here Mike Lagrone | EquiMed – Horse Health Matters).
Anyway – we ended up talking about microbes and animals and I told him about a project my lab was working on on tracking the microbes after ileal transplantation in people (see our paper on this here – the result of a collaboration between Amber Hartman in my lab and the lab of Michael Zasloff’s at Georgetown). We then discussed probiotics and he then told me an amazing story about how the old school farriers used a special method to treat horses if they were sick with some sort of gastrointestinal distress (e.g., colic). They would make the sick horse “poo tea” by taking feces from healthy horses and making it into a tea of sorts and then they served this to the sick horses. Anyway – the flight ended and he told me I should talk to some of the old school people in the Vet School at UC Davis and they might know more about it.
And then a few months later I had an interesting conversation with someone from the UC Davis Vet School – Jonathan Anderson – about horses. And as part of the conversation I told him of the discussion with Mike Lagrone and Jonathan told me there was a method called “transfaunation” which was analogous to the poo tea treatment – and was used for cows and horses and possibly other animals. Jonathan suggested I talk to Dr. Nicola Pusterla at UC Davis about this … but alas I never did.
And so – the seed of “transfaunation” and “poo tea” faded. And some things that should not have been forgotten were lost. History became legend. Legend became myth. And for four and a half years, the idea passed out of all knowledge.

But like the ring of power, transfaunation and poo tea could not be suppressed forever.  And magically, people began to talk about it over the last four years.  The human microbiome became hot.  Fecal transplants became a topic of conversation (with a little help from Carl Zimmer).  Even Colbert covered the topic.  And the final straw for me to get me to write about Mike Lagrone was when a few days ago my mom showed me an article in Scientific American by Maryn McKenna entitled “Swapping Germs: Should Fecal Transplants Become Routine for Debilitating Diarrhea?”  I knew then that the time had arrived for me to write about Mike Lagrone.  So I have.

I note, one reason I wanted to write up the story of meeting Mike Lagrone was because I personally had not noticed much in the coverage of human fecal transplants discussing the animal side of things.  This seemed a bit odd as transfaunation and poo tea and such are clearly closely connected in concept to fecal transplants in people.  A little digging (well, actually, a few Google searches) showed that many in fact have made the connection.  See for example these stories/articles:

To help those who might be interested in the animal side of “fecal transplants” I have made a mini-Mendeley collection of papers on the topic:


It is interesting to me how what goes around comes around (literally and figuratively).  This is probably a very ancient methodology – trying to move microbes from healthy individuals to sick ones to help treat them for various GI ailments.  And lets not even start talking about coprophagia which almost certainly has some “microbial colonization” component.  Thus, I conclude that, though fecal transplants in people may seem gross, it certainly makes a lot of sense that it could provide some benefits.  Not saying we know how to do it best or that it can cure everything – but it certainly seems worth pursuing in more detail.

Stay tuned – it seems very likely we will here much more about this in people over the next few years.  For some of the latest on the human side of things see
Fecal Transplants: They Work, the Regulations Don’t – also by Maryn McKenna.

Seems that medicine is catching up to what animals (and their caretakers) have known for some time …

UPDATE 1/16/2003 – Embedding my Ted talk on a related topic here


More on fecal transplants and bacteriotherapy from my blog can be found below:

Maybe the next thing is animal fecal transplant toys? #poop

OK – this is a bit gross – but whatever.  At the National Zoo the other day at the store my kids pointed out these “Pooping Animal Key Chains”.  Wonder what is next?

IMG_0061.MOV Watch on Posterous

Yes, Colbert did indeed discuss Fecal Transplants #microbeRule

See Cheating Death – Chicken Pox Lollipops & Fecal Transplants – The Colbert Report – 2011-08-12 – Video Clip | Comedy Central

The Colbert Report Mon – Thurs 11:30pm / 10:30c
Cheating Death – Chicken Pox Lollipops & Fecal Transplants

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