Well, crap - crap does a crappy job as a treatment sometimes (re: fecal trasnplants and IBD)

Well, this seems like seriously big news in the microbiome world: Fecal Tx Flunks IBD Test but Optimism High.  Charles Bankhead reports on results presented at the "Digestive Disease Week" meeting.  At the meeting Paul Moayyedi from McMaster University reported that a clinical trial of fecal microbial transplants (FMT for short) was stopped midway through the trial due to "lack of efficacy".  More specifically Bankhead reports

The investigators found no significant differences in the primary outcome or any of the secondary outcomes, which included the Inflammatory Bowel Disease Questionnaire and the EQ5D health status assessment

The researcher seems enthusiastic about FMT still but certainly this means that FMT for IBD is not going to be like FMT for CDiff (just wanted to make sure I got in a lot of abbreviations there).  I am sure there will be much more to come on FMT and it would be good to see more detail on what was presented at the meeting (a paper, or poster, or such).  But for now, this hopefully will temper some of the overselling of FMT that is going around (e.g., Overselling the microbiome award: Mercola/Perlmutter on fecal transplants for severe neurological dysfunction).

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Related posts:

• Posts tageed "overselling the microbiome"
• Posts tagged "overselling the microbiome award"
• Posts tagged fecal transplants
• Posts tagged fecal bacteriotherapy
• Transfaunation and Fecal Transplants: What Goes Around Comes Around, Literally and Figuratively
• #PLoSOne paper on the "horse #microbiome" and colitis; wonder if they will study 'poo tea'
• Human microbiome story of the month: OpenBiome fecal bank for fecal transplants
• Just in time for #ASM2013 - FDA adding regulations for fecal transplants #microbiome
• Must read microbiome paper of the month: defined microbioata treatment of Cdiff infections
• Got poo?: Clinical trial on fecal transplants (aka fecal bacteriotherapy) to treat C. difficile infections
• More (you know you wanted it) on fecal transplants and the microbiome

Overselling the microbiome award: Mercola/Perlmutter on fecal transplants for severe neurological dysfunction

Well, this is pretty scary.



An automated Google Search I have picked up a hit to an article by Mercola about an interview he did with David Perlmutter: Key Dietary Strategies to Protect Yourself from Alzheimer’s : Natural Wellness Review

And the article covers many topics but one is pretty over the top.  There is a section on recommendations by Dr. Perlmutter to promote brain health.  And one of them is quoted below:

Fecal transplantation, in cases of severe neurological dysfunction where poor gut flora appears to be a contributing factor. Your microbiome is critical for multiple reasons, including regulating the set point of inflammation, producing neurotransmitters like serotonin, and modulating systems associated with brain function and brain health. This form of therapy is now the standard of care for life-threatening C. difficile infections.

Yup.  He is recommending fecla transplants to treat severe neurological dysfunction.  Not the first person to suggest a connection between microbes and neurology.  Not the first person to say that maybe trying to change the microbiome might be an interesting thing to test as a treatment for some issues.  But with no caveats here they just jump right in to using this to treat neurological dysfunction.  This is just grossly over the top and will likely mislead many many people with neurological dysfunctions into thinking fecal transplants are a known effective treatment.  I wonder if Dr. Perlmutter will start offerring home fecal transplant kits for sale on his web site (which I will not link to here).

Now, I think microbes are important.  And I think there is potential here for fecal transplants for a lot of issues.  But potential is different than proven.  By a long show.  And people like Mercola and Dr. Perlmutter should be ashamed for misleading people like this.  And thus they are today's winners of an "Overselling the Microbiome" award.

Visualization of fecal transplants - well - thankfully - of the microbial community data not the actual transplant

I love things like this. A simple Youtube video from Antonio González Peña and Rob Knight's group. The video shows data from a study of microbial communities and how they respond to a fecal transplant. Simple. Short. And the visualization is nice.

 

Families that share everything: Health2Fit video on brother helping sister by being a donor for a fecal transplant

I guess today is fecal transplant day. So why not a little news story from Health2Fit about families that share everything ...

 

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:

• The kibosh (from Controversies in hospital infection prevention)
• Fecal transplants to treat C. diff now need FDA approval
• FDA halts US poop transplants pending further review (Raw Story). 
• FDA: Fecal Transplants Need Investigational New Drug Application ... (JWatch blog)
• Oversight for Fecal Transplants | The Daily Scan | GenomeWeb
• Many Years Young: Fecal Transplant: FDA Wants Regulation
• FDA Declares Stool a Drug -- Not kidding! @ TigerDroppings.com
• Fecal Transplant: FDA Wants Regulation - Digestive Health Center - Everyday Health - EverydayHealth.com

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.

• Fecal Bacteria Overpower Highly Contagious C. diff Strain
• Studies show fecal transplant's effectiveness treating C. diff infections
• The benefits of poop therapy
• The poop of the matter

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
• Mouse study of fecal transplants to treat Cdiff infection
• Fecal transplants in the news
• Got poo?: Clinical trial on fecal transplants (aka fecal bacteriotherapy) to treat C. difficile infections
• Episode of Radio New Zealand "This Way Up": "Meet your microbes" discussion w/ me
• Transfaunation and Fecal Transplants: What Goes Around Comes Around, Literally and Figuratively
• Maybe the next thing is animal fecal transplant toys? #poop
• Yes, Colbert did indeed discuss Fecal Transplants #microbeRule
• My science communication hero/heroine of the month - Dr. Kiki @drkiki
• More (you know you wanted it) on fecal transplants and the microbiome

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:

• Overselling the microbiome award: MedicalDaily on Effects of Sugary Drink
• The microbiome in the news: risk of overselling but not always bad coverage
• Overselling the microbiome award: Scientists look to mummies for obesity cure
• Probiotics are the new viagra & the risks of overselling of probiotics
• Overselling the microbiome award #2: The Marshall Protocol
• Overselling the microbiome award: Stephen Barrie on pre and probiotics at the Huffington Post

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UPDATE September 2017

Was just looking back at this post.  Alas the link to the Irvine web site was dead.  But thankfully the Internet Archive indexed this page. See https://web.archive.org/web/20130405021335/http://integrativemgi.com/fecal-transplantation/. It is from 2013 but may be the same as what I was seeing.

I am copying the text below

Fecal Transplantation

The gastrointestinal (GI) system is largely responsible for the well-being of every other cell and system in the body. It absorbs the nutrients which all cells require, expels toxic wastes, nurtures the complex bacterial bio-matrix which produces essential enzymes and vitamins, protects the body from invading organisms, and participates in critical “cross-talk” with the brain and the immune system.

When the bacterial communities of the intestinal tract become altered or damaged, their essential processes malfunction and the health of the individual declines – sometimes slowly, but at other times with devastating speed. When this happens, we attempt to “heal the gut,” a process that involves elimination diets, healing supplementation and probiotics. This can take many weeks or longer.

Recently, however, a new treatment has been developed that is proving highly beneficial, amazing fast, and in many cases lifesaving. Though fecal transplantation sounds unappealing, this amazingly simple procedure rejuvenates the gastrointestinal (GI) system literally overnight by taking fecal material from a healthy donor (preferably a relative), carefully processing it, and then inserting it into the colon of the patient. This is a simple and safe procedure, and, of course, the donor is thoroughly screened for communicable diseases.

The most common application of fecal transplant is in patients suffering from a serious intestinal infection caused by Clostridium difficile bacteria. Usually infections with C. diff occur following oral administration of antibiotics, and with increasing frequency the resulting infection is resistant to all antibiotic therapies. Lives have been saved and transformed in a matter of days following a fecal transplant treatment.

Exciting novel applications are evolving for fecal transplant. One is for the treatment of ulcerative colitis (UC). Patients on the verge of having their colons removed or patients living in misery with UC have experienced dramatic remissions following fecal transplants.

Another novel application involves the use of fecal transplants in obese patients. It has been discovered that in these individuals, the GI bacteria differ from those found in thin, healthy people. These so-called “fat bacteria” can extract a significantly greater quantity of calories from the same amount of food as do normal bowel bacteria. There is great hope that doing a fecal transplant on an obese individual will stimulate more appropriate bacterial behavior, and weight loss will become much easier.

Data now exists that the bacteria in the gut impacts virtually all aspects of health. Cardiovascular well-being, emotional status, bone strength, as well as immune health are all dependent on a healthy bowel flora.

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.

If you are interested in learning more about how fecal transplants can improve your health, we encourage you to call our office to schedule an appointment with Dr. Lee.

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

• 'Ick factor' not withstanding, patients would accept fecal transplants ...
• What a relief! -- Stool transplant cures Sheldon woman's C. diff ...
• RI to Host Groundbreaking Medical Trial for C. Diff

And the CNN story got picked up by Reddit

• Little-known fecal transplant cures woman's bacterial infection - 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).

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

• The Tree of Life: Transfaunation and Fecal Transplants: What Goes Around Comes Around. Literally and Figuratively  ...
• Mendeley Reference Collection on Fecal Transplants and related topics. 
• Jonathan Eisen: Meet your microbes | Video on TED.com

More (you know you wanted it) on fecal transplants and the microbiome

Image from
I Heart Guts blog

There is an interesting mini review in the Journal of Clinical Gastroenterology's September issue that may be of interest to some out there. It is entitled "Fecal Bacteriotherapy, Fecal Transplant, and the Microbiome" by Martin Floch and well, the title is indicative of the article.

Yes, the fecal transplant meme is here to stay. Sure, the cognoscenti already knew about fecal transplants. Perhaps they had read Tara Smith's discussion of it in her Aetiology blog in 2007. Perhaps they had pondered it when they read the article from my lab on intestinal transplants. Perhaps they had seenthis discussion on MSNBC, or various other stories out there such asthis or this post from Angry by Choice. Or, maybe you just learned about it from Bora's Carnival of Poop.

But the meme on fecal transplants really spread and many may have first heard about fecal transplants from Carl Zimmer's New York Times article a month or so ago "How microbes defend and define us"

In the article Zimmer discussed how Dr. Alexander Khoruts used a fecal transplant to treat a woman with a persistent and severe Clostridium infection. And Zimmer discusses how, thought such transplants had been done before, this was the first time that the microbial community was carefully surveyed before and after. (Note, my favorite part of the article is this part, where my friend Janet Jansson describes her reaction:

Two weeks after the transplant, the scientists analyzed the microbes again. Her husband’s microbes had taken over. “That community was able to function and cure her disease in a matter of days,” said Janet Jansson, a microbial ecologist at Lawrence Berkeley National Laboratory and a co-author of the paper. “I didn’t expect it to work. The project blew me away.”

Anyway Zimmer's article, as with many of his, garnered a lot of response and got many people discussing the poop on fecal transplants.

Well, this issue of the Journal of Clinical Gastroenterology may now be the biggest pile of information about fecal transplants around. That is because, in addition to this little review mentioned above, there are in fact three articles in this issue relating to fecal transplant. Alas, most of you out there will probably only be able to read the review since the other articles are behind a pay wall.

But the review is good. And I think this is not the last you will hear about this. (Though I note that, even though I think fecal transplants have some major potential, they seem to be being oversold a bit by many as some cure all -- fodder for a future "Overselling the Microbiome Award" I am sure).

I will end with this line from the review which raises some other issues about fecal transplants:

Probably one of the major problems is to define how this therapy can become socially accepted. (Can you imagine the Food & Drug Administration discussion?)

Floch, M. (2010). Fecal Bacteriotherapy, Fecal Transplant, and the Microbiome Journal of Clinical Gastroenterology, 44 (8), 529-530 DOI: 10.1097/MCG.0b013e3181e1d6e2

Grehan, M., Borody, T., Leis, S., Campbell, J., Mitchell, H., & Wettstein, A. (2010). Durable Alteration of the Colonic Microbiota by the Administration of Donor Fecal Flora Journal of Clinical Gastroenterology, 44 (8), 551-561 DOI: 10.1097/MCG.0b013e3181e5d06b

Khoruts, A., Dicksved, J., Jansson, J., & Sadowsky, M. (2009). Changes in the Composition of the Human Fecal Microbiome After Bacteriotherapy for Recurrent Clostridium Difficile-associated Diarrhea Journal of Clinical Gastroenterology DOI: 10.1097/MCG.0b013e3181c87e02

Yoon, S., & Brandt, L. (2010). Treatment of Refractory/Recurrent C. difficile-associated Disease by Donated Stool Transplanted Via Colonoscopy Journal of Clinical Gastroenterology, 44 (8), 562-566 DOI: 10.1097/MCG.0b013e3181dac035