Fecal Microbiota Transplantation (FMT's) - 90% Recovery Rate for Patients w/ C. difficile

Yes, FMT's work for people with c-diff.  There are numerous articles that will tell you so.  90% of the patients get better after FMT treatments, versus something like 30% recovery rate with the old school antibiotic treatment, which is just plain bad for treating something like this.   If the body has any healthy bacteria left, the antibiotics will be sure to kill it all - Not good.  You actually want to do the opposite of kill it and instead, replenish the body with healthy bacteria.  That's exactly what FMT's do and people get well.  

This procedure should be the first method of treatment rather than the antibiotic method. I'm not sure if the US FDA has changed their views on FMT's but with this to consider : "500,000 cases of CDI in the United States annually, with health care costs ranging from $1.3 billion to $3.4 billion." Maybe the costs could be significantly reduced by going with the more effective treatment 1st. Wouldn't that be the more logical and humane thing to do anyway?

  

Fecal transplants restore healthy bacteria and gut functions:

Fecal microbiota transplantation—the process of delivering stool bacteria from a healthy donor to a patient suffering from intestinal infection with the bacterium Clostridium difficile—works by restoring healthy bacteria and functioning to the recipient's gut, according to a study published this week inmBio, the online open-access journal of the American Society for Microbiology.

FMT & How This Treatment Will Evolve

Another report on poop that's not that shitty.  The only stuff that smells in this article is the way the AMA and FDA have responded (or lack thereof) to FMT's.  This post is about good ol' FMT's or otherwise known as - Fecal Matter Transplant's, if you're not familiar with the abbreviation. I prefer FMT when talking about this.  
So yeah, this is an article that I found on a local CA online publication. It provided a lot of information, so I decided to do a blog on this.  I read a lot of articles about FMT's, with some that have produced study data and some that do not. There's not much data out there to be found, that's probably why.  All of the articles that I have read however, have been on the positive side in regards to the results with FMT's. This is the first article that I have read to date that reports an extensive {if you want to even go that far as to call it "extensive"} follow-up with patients who had received a FMT.  This information is super important in order to show the effectiveness of the procedure and to give people the confidence to consider such a treatment.  People get grossed, they just do. It's the way our culture handles stuff like this. The point I want to make here is that because of the lack of testing and trials for FMT's, being able to know if this procedure is effective and safe, is to follow-up with patients that have been treated with FMTs. Those patients, in a sense, will provide helpful and needed information that cannot be found in clinical trial data because the data doesn't exist.   This procedure is so new {well,to us Westerners that like to deny and refuse anything "natural"} and not tradition, the patients receiving this treatment are essentially the trial subjects. Seriously, there should be a consent that patients must sign before they receive this treatment that allows the doctors to use their information anonamously, especially follow up data, so it can be published for learning purposes.  To have that information available is crucial.  We are talking about working with US FDA here! As we have seen and continue to see, the FDA doesn't always make the most logical/reasonable decisions in the best interest of the people.  To be able to show data that makes a difference, will make this life saving treatment available to people that would otherwise die. There is no reason why there should be  hundred of thousands of people suffering from c-diff, thousands who end up dying and BILLIONS of dollars spent on ineffective treatments!  That's insanity when there's a treatment that has shown to be 90% effective.  
A patient that suffered from c-diff states the following -  "It's a beast that keeps storming back," he said. "It affects the mind and emotions, too — 90 percent of serotonin is in the gut. You worry quite a lot."  The doctors in this article state that the infection disrupts a person's life.  Doctor Stollman states that FMT's are "the most patient-driven treatment he's encountered in his twenty-plus years of practicing medicine".  It's not surprising that when you have a condition that won't go away, no matter how many rounds of treatment you take, that people end up seeking out the strange and unusual if it means being healthy again.  
The AMA needs to make a billing code !  Doctors need to get paid for treating people AND  doctors need to consider offering FMT's as an option that they know they will get paid for.  After all, the FDA has allowed people with a difficult case of c-diff to get treated with this procedure.  Which means = if you're most likely going to die from c-diff, THEN you can receive the treatment. *smh* Yup, only if you have suffered long, spent a lot and have no more fight in you, will you be able to get an effective treatment.  Does this make any sense whatsoever?  
One last point.  The 4 patients out of the 77 that were followed up with after the FMT who had developed one of the health issues listed (I highlighted the paragraph in purple), in my opinion probably has no relationship to the FMT.  People could have other health issues brewing that just happen to appear after this procedure.  The 4 health conditions are all very different from each other which also leads me to believe that these illnesses weren't brought on by the FMT.  I just feel that as long as the sample donor is screened and cleared for all the diseases that could make a donor  not qualified, then the chances of something negative happening is probably very low.  It's like receiving blood.  The benefit of getting it is high (because if you're getting a blood transfusion, there's a need for it) and the risk is low. Whether it's in a form of transplant or pill, if  it makes people better, this should start to be considered THE most effective treatment rather than the alternative when all else fails.  That's my take on it. 

Fecal Transplantation Helps Kids w/ Ulcerative Colitis #UC study shows

Sounds promising from everything i've read and continue to read.  

• How do they get the fecal microbes into the person? According to the article, this is how it's done.  "To perform the transplant, a stool sample must be provided by a healthy adult, usually a family member or close friend. It is mixed with a saline solution and filtered to remove particles that could block the tube. It is given to the patient as an enema in a process that takes more than an hour." 

"Hey sheester, can you s*** in this cup please?"  How does one go about obtaining someones poop?  Hand them the bag with the sample cup and say "# 2 ..not 1."  If they look at you weird and they will, i'm certain.  Say "just do it, it's for a good cause"  

The ultimate probiotic: Unusual treatment helps kids with ulcerative colitis, study shows | MLive.com:

GRAND RAPIDS, MI – Life can be miserable for a kid who has ulcerative colitis.

Bouts of severe diarrhea, cramping and pain can cause them to miss school or avoid social activities. Medications to treat the condition can cause severe complications. The disease can delay growth. Some kids eventually have to undergo surgery to remove their colon.

That is why an alternative, drug-free treatment is raising hope – even as it raises eyebrows among those unfamiliar with it.

At  Helen DeVos Children’s Hospital, a pediatric gastroenterologist is getting good results for patients using fecal transplants. Stool from a healthy donor – often a parent - is given to the patient through an enema in an attempt to restore healthy bacteria in the child’s intestine.

“It’s the ultimate probiotic,” said Dr. Sachin Kunde.

Kunde conducted the first clinical trial in the country to study the use of fecal microbial transplantation on children with ulcerative colitis. Only 10 patients were involved in the trial, but the results were promising.

BY THE NUMBERS

Ulcerative colitis is a type of inflammatory bowel disease that affects the lining of the large intestine and rectum.• 1.4 million Americans suffer from inflammatory bowel disease
• 700,000 have ulcerative colitis
• One in four patients is diagnosed in childhood
SOURCE: CCFA 

The symptoms cleared up in three of the children – and they stayed symptom-free for at least a month. Another six saw improvements, which also lasted at least a month. For example, the number of daily bowel movements may have dropped from 10 to five, Kunde said. One child was unable to retain the enema.

The results of the study were published online by the Journal of Pediatric Gastroenterology and Nutrition and will be featured in the June print edition.

The study has stirred excitement among parents of children and young adults with ulcerative colitis, a form of inflammatory bowel disease that affects the lining of the large intestine or rectum.

“We had at least 50 patients in one year calling to be enrolled in the study,” Kunde said. “They want it because they don’t want medication. They think this is a fix.”

But Kunde balanced hope with caution. A larger study is needed to test the treatment’s effectiveness, he said. He has applied for funding for further research and is looking into whether the experimental treatment can be offered outside of a research setting.

Kunde said he first thought of using fecal transplants to treat ulcerative colitis during his fellowship at Emory University in Atlanta. They have previously been used experimentally to treat C. difficile infections.

Within a month of joining DeVos Children’s Hospital in 2011, he proposed the clinical trial to the Spectrum Health institutional review board. He also had to obtain approval from the Food and Drug Administration, because human stool is considered a drug and a biologic.

To perform the transplant, a stool sample must be provided by a healthy adult, usually a family member or close friend. It is mixed with a saline solution and filtered to remove particles that could block the tube. It is given to the patient as an enema in a process that takes more than an hour.

“We believe that the procedure may restore ‘abnormal’ bacteria to ‘normal’ in patients with ulcerative colitis,” Kunde said.

The pilot study involved 10 children and young adults, ages 7 to 20. They received a treatment a day for five days, and then their symptoms were evaluated.

Hospital staff made sure the patients did not see or smell the fecal transplant, which decreased anxiety and uneasiness about it. Kunde said awareness about the treatment is needed so people will readily see it as an acceptable option.

However, many struggling with severe symptoms of ulcerative colitis – adults and children – don’t need convincing, Kunde said. The disruption of life can be a significant psychological burden on patients and their families.

“People want this to be gone,” he said. “I don’t know if it will be gone or not. But it is a new hope for them.

“If we can help at least 30 percent of the patients, that is important.”

Contact Sue Thoms: Email. Twitter. Facebook.

http://www.mlive.com/news/grand-rapids/index.ssf/2013/04/fecal_transplant_-_the_ultimat.html

Donor Feces Cure Recurrent Diarrheal Infection, Study Shows - Bloomberg

Ummmm lol I still don't know about this.  There's just something that seems wrong about receiving an infusion..... of feces!



Donor Feces Cure Recurrent Diarrheal Infection, Study Shows - Bloomberg:

An infusion of feces through the nose beat the standard antibiotic as a treatment for a recurrent diarrhea-causing infection that kills about 14,000 Americans a year, a study showed.

In a trial among 43 people with recurrent diarrhea caused by a persistent bug called Clostridium difficile, 81 percent of those who received an infusion of feces from a healthy donor after treatment with vancomycin were cured, compared with only 31 percent of those treated with the drug alone, researchers from the University of Amsterdam wrote in an article published yesterday by the New England Journal of Medicine. The study was stopped early because the treatment was clearly working.

The results validate an approach called fecal microbiota transplantation, or FMT, pioneered in 1958 by doctors in Denver, and provides an alternative for the approximately one-in-four patients whose infection isn’t cleared by initial antibiotic treatment. C. difficile is the most common cause of hospital- acquired infectious diarrhea in the U.S. and costs about $1 billion a year to treat, according to the Centers for Disease Control and Prevention.

“Only patients with the most recalcitrant cases of C. difficile infection are likely to undergo FMT, usually out of desperation after multiple treatment approaches have failed,” Ciaran Kelly, a professor of medicine at Harvard Medical School, wrote in an editorial accompanying the study. The use of feces may be eliminated by the use of cultured bacteria that make the recipient resistant to C. difficile, Kelly said.

Restoring Bacteria

The procedure probably works by restoring normal gut bacteria, the researchers, led by Els van Nood, wrote in the study, which was funded by the Netherlands Organization for Health Research and Development and the Netherlands Organization for Scientific Research.

Vancomycin is sold as Vancocin by ViroPharma Inc. (VPHM) Vancocin accounted for $289 million in sales in 2011, more than half of Exton, Pennsylvania-based ViroPharma’s revenue.

A federal judge last week dismissed the company’s lawsuit against the U.S. Food and Drug Administration over generic forms of the antibiotic developed by Akorn Inc. (AKRX) and Watson Pharmaceuticals Inc. (WPI)

Optimer Pharmaceuticals Inc. (OPTR)’s Dificid, approved for sale in the U.S. in May 2011, was the first drug cleared for the infection in 25 years.

By Simeon Bennett - Jan 17, 2013 6:28 AM ET

Fecal transplants cure diarrhea!! Wow what will they think of next

Interesting!!! Nuff said about this one.

Fecal transplants cure diarrhea, modulate testosterone levels

Nutella was not used as a placebo control.

by John Timmer - Jan 18 2013, 1:35pm EST

From some perspectives, we humans aren't really so much individuals as we are walking ecosystems—our bodies carry more bacterial cells—with their own genomes and agendas—than the total count of human cells we're composed of. Bacteria cover our skin, get to our food before we have the chance to absorb it, and in many cases stay helpfully out of the way of the immune system.

Given all that, it shouldn't be a surprise that we're finding that bacteria can have significant effects on the human body in ways that go well beyond causing an infection. Two articles that appeared this week drive that home. In one, doctors cured a recurring, diarrhea-causing infection simply by transplanting gut bacteria from a healthy individual. And in the second, the bacterial transplants altered the progression of type 1 (autoimmune) diabetes in mice—by altering the animal's testosterone levels.

Fighting bacteria with bacteria

Clostridium difficile, or C. diff, is a bacteria that tends to cause extended bouts of diarrhea. In about 20 percent of the cases that end up under a doctor's care, it will get into the digestive system and refuse to come back out, creating recurring bouts of illness that don't respond to most antibiotics. At that point, the standard of care is an intensive course of vancomycin, which only works in about 60 percent of patients. With each further recurrence, the rate of success goes down even further.

Anecdotal evidence and case reports had suggested that the problem wasn't so much the presence of C. diff as the fact that it had grown out of balance with the rest of the gut's bacterial ecosystem. To get the gut back into balance, fecal transplants had been tried and, anecdotally at least, they worked. So some doctors in the Netherlands decided to do a clinical trial, comparing a fecal transplant to standard care with vancomycin. The trial was what the researchers called "open label," meaning that people were aware they were having a feeding tube stuffed down their nose to deliver someone else's poop into their body. (A Twitter pundit suggested a Nutella infusion might make for a good placebo control.)

A few dozen healthy volunteers were screened for a huge panel of infectious diseases, and those who came through clean were asked to rush their bodies' first deliveries of the day to the hospital, where it was mixed with saline and had the particulates removed. The results then went into the gastro-nasal tube, given to patients after their original gut flora had been cleared out by a "bowel lavage."

The authors had originally planned to get 40 patients for each group, but the fecal transplants were so successful, they stopped the trial after only 16 patients had received a transplant. Of these, 13 (80 percent) were cured after a single transplant. Two of the remaining three were cured after their second, bringing the success rate up to over 90 percent. In contrast, the success rate of vancomycin treatments was down around 30 percent.

The biggest problem? Enrolling patients. Most people who agreed to participate in the trial only did so after conventional treatments failed several times, "reflecting the reluctance of patients and physicians to choose donor-feces infusion at an early stage."

Bacteria, sex, and immunity

It's easy to view this as a demonstration of the hygiene hypothesis, which posits that all sorts of health issues are linked to exposure to a variety of infectious agents, which the immune system then learns to live in harmony with. But a second paper appeared this week that cautioned against viewing things as being quite that simple.

The paper focused on the progression of type 1 diabetes, which is the product of an autoimmune attack on the insulin-producing cells. There's a special strain of mice, called NOD (for non-obese diabetic) that are prone to developing this disorder. The mice show properties that are very much like the human version of the disease: it's genetically complex, the progression is influenced by environmental factors, and it strikes females more severely than males.

And, unexpectedly, it's influenced by gut bacteria. There was some hint of this, given that other researchers had shown that a systematic exposure to bacterial proteins was able to suppress the development of the disease. But the authors found an unexpected effect when they tested how the disorder progressed in mice raised in germ-free conditions. Rather than accelerating the development of symptoms in all mice, the germ-free conditions accelerated the progression in males, making them (at least in this assay) indistinguishable from females.

So the researchers tried an experiment: they took germ-free NOD mice and did a fecal transplant from adult male animals (mice are naturally coprophagic, so the mice took a lot less convincing than did the humans). When female NOD mice received gut bacteria from males, it actually slowed the disease progression down. The apparent sex difference in autoimmune function was mediated in part by gut bacteria.

Your first thought might be that testosterone in males could create a different environment in the gut, causing it to host a different diversity of species. It's a reasonable guess, but it's wrong. Instead, the researchers found that the transplant of gut bacteria caused a surge in testosterone production by females that lasted for up to 14 weeks. This had no effect on the female's fertility, but it did clearly alter immune function. If the authors injected these mice with a testosterone inhibitor, the diabetes protection went away.

All of which indicates that the other intuitive idea—that gut bacteria influence immune function by interacting directly with immune cells—also can't be right, or at least can't be everything. Clearly, the production of testosterone, by whatever cells may be producing it, plays a key role.

Although the papers argue against some of the simpler views of human health—bacteria are all bad, or not having exposure to pathogens means an overactive immune system—they both argue that viewing our bodies as a complex ecosystem can help provide insight into human health.

New England Journal of medicine, 2013. DOI: 10.1056/NEJMoa1205037 and Science, 2013. DOI:10.1126/science.1233521  (About DOIs).

Fecal transplants cure diarrhea, modulate testosterone levels | Ars Technica:

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