On the blog of the popular but respected Mother Jones magazine is an article on the current regulatory environment for fecal transplants for C diff [Clostridium difficile] in the US and likely developments at the federal level.

Should We Regulate Poop As a Drug? The future of fecal transplants, and a bevy of entrepreneurs, hinges on how the FDA decides to regulate the procedure.www.motherjones.com/environment/2014/08/...iome-rebiotix?page=1

There is definitely progress in this area. Last year the National Institutes of Health (NIH) and the federal Food and Drug Agency (FDA) agreed physicians could perform the procedure albeit with lots of permissions and paperwork. Alternately, two companies have proposed pre-packaed and stabilized enemas, that are currently undergoing clinical trials with the. But is approval as a drug appropriate for something like feces, which varies so radically from person to person?

A few weeks after the meeting at NIH, the FDA changed its approach. Fecal transplants would still be regulated as a drug, but to keep them moving (at least until a treatment was finally approved), the agency said it would exercise "enforcement discretion"—meaning health care providers could go on administering transplants for recurrent C. diff patients without filing paperwork for new drugs.

In February 2014, the FDA issued a second draft of its guidelines. The Infectious Diseases Society of America, a 10,000-member organization of doctors and scientists, offered a blanket endorsement of the FDA's position.

Chris, you are pioneer.

This paper is about small vs. large intestinal C. diff overgrowth where the problem is normally considered large intestine. Because the problem is now also viewed as small intestinal, intranasal FMT may be gaining traction:
www.gutpathogens.com/content/1/1/7

How this relates to sanitation is of great interest because small intestinal infection/gut dysbiosis is likely the main problem. The small intestine is where nutrient absorption takes place. It's also the site of the most nerves in the body, including and especially the vagus nerve, a crucial gut-brain connection.

So, with small intestinal microbial overgrowth (bacteria, fungi, protozoans, worms), there is malabsorption syndrome which is still confused with malnutrition leading to mental and physical ill health. It's also known vaccines are ineffective in light of poor sanitation because vaccines rely on gut microbiota to work. The small intestine is meant to be relatively sterile compared to the large intestine. What would not be pathogenic in the large intestine can become a "pathogen" in the small intestine.

Hi,

I have been studying this for a while now, and find FMT to be very interesting and to have great potential.

thepowerofpoop.com/ is a great website that was set up by the patients themselves, many of whom have cured themselves at home with instructions shared by other patients. This is a very interesting case of the power of the internet.

Infusion, if via a tube through the nose, has to go past the stomach, since the acidity there would otherwise kill lots of the bacteria.

Here is an excerpt from the very respected Mayo Clinic's website
www.mayoclinic.org/medical-professionals...90-percent-cure-rate
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The sky is the limit

Fecal transplantation has generated "a lot of buzz for lots of illnesses," Dr. Orenstein says, and both he and Griesbach feel the procedure's potential has barely been tapped.

"Its use in C. difficile has been well established, but much of the rest is mainly anecdotal," he says. "There is some baseline evidence that it might be effective for IBS, but that hasn't been looked at in a controlled manner. Some physicians claim to have great success treating ulcerative colitis and celiac disease. And it's been looked at for obesity, diabetes and rheumatoid arthritis because some of the signals for the gut are pro-inflammatory for RA. But it's difficult to get real data." ...

Noting that FMT shows some potential for treating Parkinson's disease, Griesbach says she is excited about future interest in the procedure within the institution. "It is crucial to start getting data so these projects can move forward. It's only limited by our desire, imagination and cost," she says.

"The microbiome of the gut is not inactive; it's diverse and plays many roles in health and well-being that are just now being explored," Dr. Orenstein points out. "With molecular biology and the sequencing of these species, this can only get bigger. It's like the beginning of the space program."
---

The main limitation here is Fecophobia (that irrational fear of feces). Recent microbiome studies are showing that there are many more microbes in and on us than was ever imagined and most cause no trouble. In many cases, the bad ones have a party when we have knocked out the good ones with antibiotics.
www.sciencemag.org/site/special/gut_micro/

My wife, who is an indigenous Shuar medicinal plant expert, and I offer natural medicine to people in the Omaere Ethnobotanical Park (omaere.wordpress.com) that we manage in Puyo, Ecuador, and I would like to start offering FMT to those who would benefit from it.

This is an interesting discussion, from a broader perspective of human health. Among other things, if fewer people have digestive problems, there will be fewer pathogens to be controled by sanitation and less risk overall.

Best wishes,
Chris Canaday

This article made an impression on me regarding the severity of CDI/CDAD. The patient described in this article; lost 27 kgs, was confined to a wheelchair, had small bowel movements every 15 minutes ... All other conventional treatment had no effect. In those circumstances, taking a risk seems perfectly justifiable.

Joe, you'll be happy to learn about the first "poop bank" opening earlier this year to screen donors for fecal transplants:
www.boston.com/news/science/blogs/scienc...uimWYIjJoJ/blog.html

The intranasal route is to access the small intestine. The more conventional route is to access the large intestine (colon) where benefits reverberate to the small intestine, often the site of infection including Clostridium difficile where fecal transplant has been more successful by far than conventional drug treatment.

Many people are performing their own FMTs; several videos on youtube explain the process. I know someone who's done it DIY and believes it saved her life.

Cheers for your post.

Thanks all. I have been looking at scientific papers - and none of them involve transplants to the stomach.

It is, however, possible that the journalist has some of the detail wrong, as there are studies where the large intestine is transplanted with faecal material via the nose (I'm no medic, so I have no idea how this is done).

There is a lot of recently published work, in addition to Patrick's links this in Nature is interesting regarding policy and regulation:

www.nature.com/news/policy-how-to-regula...-transplants-1.14720

Edit: this also looks interesting: journals.lww.com/co-gastroenterology/Abs...n___facts_and.6.aspx

Note the last line of the abstract: "Currently, FMT should only be given in a strict experimental setting for other conditions than CDI."

I have also been following this a little bit in the news. Not because I know much about these types of diseases, but because it seems to me another piece in the puzzle to add real "value" to our faeces instead of just seeing them as nasty waste that should not even be mentioned in conversation...

My simplistic view: If we have blood transplants, why not also faeces transplants if it helps (drinking urine is also practiced around the world for many perceived health reasons).

I hope this treatment - which would also be rather low-cost, I assume - will help some people who are suffering from constant diarrhoea for example.

See also this article in mainstream media:
www.abc.net.au/news/2014-03-18/sydney-do...ing-diseases/5329836

+++++

First part of the article:

Doctor Tom Borody claims faecal transplants curing incurable diseases like Crohn's

Lateline By Kerry Brewster
Updated Wed 19 Mar 2014, 1:54pm AEDT


An Australian doctor claims he is curing incurable diseases using an all-natural waste product we usually flush away - human stool.

Professor Tom Borody has been championing the treatment, known as faecal microbiota transplantation (FMT), for 25 years.

As modern science begins to appreciate the critical role gut bacteria plays in human health, his treatment of diseases including Crohn's and colitis, auto immune diseases and even neurological disease is provoking both criticism and excitement.

While some doctors regard faecal transplants as potentially dangerous, two of Australia's biggest teaching hospitals are embarking on a large national trial.

Professor Borody is at science's new frontier, manipulating the bacteria that live in the human gut.

"In terms of genetics there are 3.1 million genes. That's a hell of a crowd of individuals living in our colon," he said.

Patients travel to his Sydney clinic from as far as the UK. Many are seriously ill. They come for FMT, where donor human stool is injected into their intestines or colons.

"We know that bacteria manufacture active anti-microbial molecules so when we infuse these new bacteria they are like a factory of antibiotics that have gone in there and they weed out and kill the bug that we cannot identify," Professor Borody said.

FMT is now recognised in the US as a first line treatment to combat an epidemic of the antibiotic-resistant and often deadly gut bacteria, C.difficile.

But Professor Borody claims he has also cured dozens of colitis and Crohn's cases, gut diseases regarded as incurable.

"I think it's a hell of a breakthrough to say we can cure colitis," he said.

[...]

There is always some risk involved with medical procedures. Risk management is not about totally eliminating risk, but to reduce the risk to an acceptable level. Thus if a methodology that minimizes the risk to an acceptable level could be developed I see no reason why this technique should not be done. And to be fair it seems that fecal transplantation is used as a last resort, only when conventional treatment does not work.

This article has a discussion regarding the safety issues. Apparently there is a need of standardization of the screening.

The transplant is not always done into the stomach. It can also be done through colonoscopy, where it is directly transplanted into the colon. This article compares the colonoscopic and nasogastric transplantation. The article brings up the concern with a higher exposure to the gastrointestinal tract when using nasogastric transplantation.

I saw the following article and thought it might be interesting to discuss.

There have been proper trials of faecal transplants, but it appears that at least one anaesthesitist in Australia has taken to performing human faeces transplants to his patients via the nose to the stomach.

www.theguardian.com/world/2014/may/08/hu...as-superbug-medicine

This seems to me (as it is written here) to be a monumentally stupid idea. Apart from anything else, surely the transplant would need to be to the gut rather than the stomach to be effective. Are the 'donors' properly screened? How does the doctor know that the donor is not carrying a disease that the patient is susceptible to?

I can see the rationale behind faecal transplants, but unless the controls are at least as stringent as blood, then the potential for disease transfer seems very high.

Thoughts?