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Fecal Transplantation
From Reuters Health Information
Fecal Transplants Conquer C. Difficile Infections
By Kate Kelland, Health and Science Correspondent
LONDON (Reuters) Jan 19 - Once a year, every year, Professor Thomas Borody receives a single-stem rose from one of his most grateful patients. She is, he says, thanking him for restoring her bowel flora.
It's a distasteful cure for a problem that's increasingly widespread: Clostridium difficile infections can be hard to treat with antibiotics. But Dr. Borody is one of a group of scientists who believe the answer is a fecal transplant.
Some jokingly call it a "transpoosion." Others have more science-y names like "bacteriotherapy" or "stool infusion therapy." The process involves replacing a person's feces with someone else's, and in the process, giving them back the normal intestinal flora they desperately need.
Dr. Borody's grateful patient, Coralie Muddell, suffered months of chronic diarrhea so bad she would often embarrass herself in public, and had even stopped eating to try to halt the flow.
The technique that cured her has had a success rate of around 90% in the experimental cases where it has been used so far. Now scientists are taking it to the next level, with randomized controlled trials to establish whether it can really be a viable option when antibiotics have failed.
With rates of hospital-acquired C. difficile infection rising in the U.S., Europe and other parts of the world, that could save lives as well as reducing expensive days of extra care. "There's rising recognition of how effective this is," Dr. Borody, a gastroenterologist based in Sydney, Australia, told Reuters.
YUCK FACTOR
There's little doubt this treatment has an image problem. Feces, including important bowel flora, is transferred from a volunteer donor -- screened to limit possible other infections -- into the colon of the infected patient. The treatment can be administered by a colonoscope or an enema, or by the mouth or the nose.
"I used to be frowned upon and called 'the doctor who makes people eat ****,'" said Dr. Borody, whose scientific papers have included such titles as "Flora Power" and "Toying with Human Motions." But he is also deadly serious. One of his published studies reported that in patients with recurrent C. difficile infection, 60 out of 67 (90%) of those who received fecal transplants were cured.
Dr. Alex Khoruts, a gastroenterologist at the University of Minnesota Medical School in the United States, agrees that the science is not to be sniffed at. "The data are very strong," he said in a telephone interview. "There is no question that it works."
Dr. Khoruts published a study in the Journal of Clinical Gastroenterology in 2009 that showed a single infusion of feces reversed the absence of bacteroides -- a group of bacteria vital to the body's ability to withstand infections with C. difficile.
Dr. Khoruts often sees patients who have taken course after course of antibiotics. As soon as the treatment stops, the infection returns. It doesn't take much for these sufferers to listen to a new treatment idea, even if it involves feces.
"The patients I see don't have any qualms about it," he says. "By the time I see them, they've often been sick for anywhere from 6 months to 2 years, so they're quite desperate. Nothing really scares them."
The main aim, he says, is to "keep the poo pure."
"What we try to do is preserve it as close as possible to how it was in the donor. There's no in-between culture or enrichment. We want to transfer as much as we can intact."
The donor feces is filtered to remove some larger particles and then "simply goes through a blender," Dr. Khoruts explained, with a saline solution to liquefy it before it is administered.
He favors methods that avoid going in through the mouth or the nose, which he says may make patients gag.
Dr. Borody's clinic, at the Centre for Digestive Diseases in New South Wales, acknowledges that using a nasojejunal tube -- which goes in through the nose, down the throat and into the stomach -- is not the most attractive method, but argues it is the most reliable way of killing the C. difficile bug and its spores once and for all.
C. DIFFICILE ON THE RISE
Repellent as fecal transplants may seem, if C. difficile trends continue, demand could rise rapidly.
A Europe-wide study published in The Lancet late last year found the incidence of C. difficile infections in hospitals in the region had risen to 4.1 per 10,000 patient days in 2008 from 2.45 per 10,000 patient days in 2005.
The infections can have a range of consequences, from severe diarrhea to blood poisoning, colitis and death.
A 2008 report from the Association for Professionals in Infection Control and Epidemiology (APIC) found that on any single day in U.S. hospitals, there could be 7,000 infections with C. difficile and up to 300 deaths.
The most commonly used antibiotic for C. difficile is metronidazole, and some more severe forms are treated with vancomycin, traditionally seen as the antibiotic of last resort. Like other bacteria, C. difficile can develop resistance to vancomycin, giving it multi-drug-resistant traits that make treatment extremely difficult or impossible.
Dr. Khoruts cites data from 1958, when some of the first scientific papers on the use of fecal transplants were published. They showed the death rate for patients with a type of infection called fulminant C. difficile colitis was 75%.
"Then if you go forward to 2010 -- 52 years later, with the best current medical care and new antibiotics -- the mortality is still 50%," he said. "So we really can't say standard medicine has done that well in 50 years."
"POO IS THE ONLY ANSWER"
Dr. Khoruts now fears that unless the medical establishment embraces the technique, "the majority of people who could benefit from this procedure are not going to get it." Borody says "Poo is the only answer." So why is it not catching on?
Scientific literature over half a century has documented the use of fecal transplants, but the technique has remained on the fringes of medicine. Some experts say a lack of robust trial data may be holding people back -- as well as the obvious and natural aversion to feces as a medicinal product.
To try to address this, a team of specialists in the Netherlands is recruiting around 100 sick and healthy people into a randomized controlled trial to see if the method can be proven.
Although the study is still under way, Dr. Ed Kuijper of the Leiden University Medical Centre, one of those working on it, says the early signs are that fecal transplants will be shown to be effective in patients with recurrent C. difficile infections.
Tackling the image problem is more challenging; but both Drs. Khoruts and Kuijper say scientists are "not very far away" from being able develop a kind of artificial feces that might help.
Laboratory-grown feces would be like a super probiotic, they say, but more powerful by far than any yogurt drink you can buy in a supermarket. It would have the qualities of donor feces without the marketing issues.
"It would be a good idea if synthetic poo would work," says Borody. But he has doubts -- and until he sees some good results with artificial feces, he's sticking with the real thing. "We'd like to get away from poo, but it works the best."
http://www.medscape.com/viewarticle/736025?src=mp&spon=3
Fecal Transplants Conquer C. Difficile Infections
By Kate Kelland, Health and Science Correspondent
LONDON (Reuters) Jan 19 - Once a year, every year, Professor Thomas Borody receives a single-stem rose from one of his most grateful patients. She is, he says, thanking him for restoring her bowel flora.
It's a distasteful cure for a problem that's increasingly widespread: Clostridium difficile infections can be hard to treat with antibiotics. But Dr. Borody is one of a group of scientists who believe the answer is a fecal transplant.
Some jokingly call it a "transpoosion." Others have more science-y names like "bacteriotherapy" or "stool infusion therapy." The process involves replacing a person's feces with someone else's, and in the process, giving them back the normal intestinal flora they desperately need.
Dr. Borody's grateful patient, Coralie Muddell, suffered months of chronic diarrhea so bad she would often embarrass herself in public, and had even stopped eating to try to halt the flow.
The technique that cured her has had a success rate of around 90% in the experimental cases where it has been used so far. Now scientists are taking it to the next level, with randomized controlled trials to establish whether it can really be a viable option when antibiotics have failed.
With rates of hospital-acquired C. difficile infection rising in the U.S., Europe and other parts of the world, that could save lives as well as reducing expensive days of extra care. "There's rising recognition of how effective this is," Dr. Borody, a gastroenterologist based in Sydney, Australia, told Reuters.
YUCK FACTOR
There's little doubt this treatment has an image problem. Feces, including important bowel flora, is transferred from a volunteer donor -- screened to limit possible other infections -- into the colon of the infected patient. The treatment can be administered by a colonoscope or an enema, or by the mouth or the nose.
"I used to be frowned upon and called 'the doctor who makes people eat ****,'" said Dr. Borody, whose scientific papers have included such titles as "Flora Power" and "Toying with Human Motions." But he is also deadly serious. One of his published studies reported that in patients with recurrent C. difficile infection, 60 out of 67 (90%) of those who received fecal transplants were cured.
Dr. Alex Khoruts, a gastroenterologist at the University of Minnesota Medical School in the United States, agrees that the science is not to be sniffed at. "The data are very strong," he said in a telephone interview. "There is no question that it works."
Dr. Khoruts published a study in the Journal of Clinical Gastroenterology in 2009 that showed a single infusion of feces reversed the absence of bacteroides -- a group of bacteria vital to the body's ability to withstand infections with C. difficile.
Dr. Khoruts often sees patients who have taken course after course of antibiotics. As soon as the treatment stops, the infection returns. It doesn't take much for these sufferers to listen to a new treatment idea, even if it involves feces.
"The patients I see don't have any qualms about it," he says. "By the time I see them, they've often been sick for anywhere from 6 months to 2 years, so they're quite desperate. Nothing really scares them."
The main aim, he says, is to "keep the poo pure."
"What we try to do is preserve it as close as possible to how it was in the donor. There's no in-between culture or enrichment. We want to transfer as much as we can intact."
The donor feces is filtered to remove some larger particles and then "simply goes through a blender," Dr. Khoruts explained, with a saline solution to liquefy it before it is administered.
He favors methods that avoid going in through the mouth or the nose, which he says may make patients gag.
Dr. Borody's clinic, at the Centre for Digestive Diseases in New South Wales, acknowledges that using a nasojejunal tube -- which goes in through the nose, down the throat and into the stomach -- is not the most attractive method, but argues it is the most reliable way of killing the C. difficile bug and its spores once and for all.
C. DIFFICILE ON THE RISE
Repellent as fecal transplants may seem, if C. difficile trends continue, demand could rise rapidly.
A Europe-wide study published in The Lancet late last year found the incidence of C. difficile infections in hospitals in the region had risen to 4.1 per 10,000 patient days in 2008 from 2.45 per 10,000 patient days in 2005.
The infections can have a range of consequences, from severe diarrhea to blood poisoning, colitis and death.
A 2008 report from the Association for Professionals in Infection Control and Epidemiology (APIC) found that on any single day in U.S. hospitals, there could be 7,000 infections with C. difficile and up to 300 deaths.
The most commonly used antibiotic for C. difficile is metronidazole, and some more severe forms are treated with vancomycin, traditionally seen as the antibiotic of last resort. Like other bacteria, C. difficile can develop resistance to vancomycin, giving it multi-drug-resistant traits that make treatment extremely difficult or impossible.
Dr. Khoruts cites data from 1958, when some of the first scientific papers on the use of fecal transplants were published. They showed the death rate for patients with a type of infection called fulminant C. difficile colitis was 75%.
"Then if you go forward to 2010 -- 52 years later, with the best current medical care and new antibiotics -- the mortality is still 50%," he said. "So we really can't say standard medicine has done that well in 50 years."
"POO IS THE ONLY ANSWER"
Dr. Khoruts now fears that unless the medical establishment embraces the technique, "the majority of people who could benefit from this procedure are not going to get it." Borody says "Poo is the only answer." So why is it not catching on?
Scientific literature over half a century has documented the use of fecal transplants, but the technique has remained on the fringes of medicine. Some experts say a lack of robust trial data may be holding people back -- as well as the obvious and natural aversion to feces as a medicinal product.
To try to address this, a team of specialists in the Netherlands is recruiting around 100 sick and healthy people into a randomized controlled trial to see if the method can be proven.
Although the study is still under way, Dr. Ed Kuijper of the Leiden University Medical Centre, one of those working on it, says the early signs are that fecal transplants will be shown to be effective in patients with recurrent C. difficile infections.
Tackling the image problem is more challenging; but both Drs. Khoruts and Kuijper say scientists are "not very far away" from being able develop a kind of artificial feces that might help.
Laboratory-grown feces would be like a super probiotic, they say, but more powerful by far than any yogurt drink you can buy in a supermarket. It would have the qualities of donor feces without the marketing issues.
"It would be a good idea if synthetic poo would work," says Borody. But he has doubts -- and until he sees some good results with artificial feces, he's sticking with the real thing. "We'd like to get away from poo, but it works the best."
http://www.medscape.com/viewarticle/736025?src=mp&spon=3
I wasn't Googling Kathy. I subscribe to many different alerts about HCV, liver disease, organ transplantation and gastroenterology. When I get the email alerts I look at the titles of the articles and follow up on what interests me. I couldn't imagine what the title of the subject article referred to vis-a-vis a medical procedure so I took a look at it.
I couldn't resist sharing it because although there is a humorous aspect here there may also be a viable approach to a very serious disease.
I hope all is well with you Bean.
Mike
I couldn't resist sharing it because although there is a humorous aspect here there may also be a viable approach to a very serious disease.
I hope all is well with you Bean.
Mike
I couldn't resist sharing ....
Oh, so glad you did. I ought to let old fishdoc know there is a good poop thread again. Too bad she can't remember her password.
I am good Mike. Just biding my time . THis summer should be interesting on MHY.
Kathy
Oh, so glad you did. I ought to let old fishdoc know there is a good poop thread again. Too bad she can't remember her password.
I am good Mike. Just biding my time . THis summer should be interesting on MHY.
Kathy
I have been known to say "eat -hit and die"' Never thought it would make one healthy""'
All thanks for the education and the laughter.. I think I can sleep now finally.. I must say I could not bear to read it all. yuck, but enjoyed the humor that came out of all with the P transplant... Watch out goofy dad..." This one brought out some other Goofys..." lol...
All thanks for the education and the laughter.. I think I can sleep now finally.. I must say I could not bear to read it all. yuck, but enjoyed the humor that came out of all with the P transplant... Watch out goofy dad..." This one brought out some other Goofys..." lol...
Now at long last I can truly say Mike you have brought us a load of $hit ; )
I suppose now someone will have to invent a collection vehicle...
the Brown Cross maybe??? Now there's an image!
hilarious!!
mb
I suppose now someone will have to invent a collection vehicle...
the Brown Cross maybe??? Now there's an image!
hilarious!!
mb
C. Difficile Yields to Novel Antibiotic
By Todd Neale, Staff Writer, MedPage Today
Published: February 02, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.
The investigational antibiotic fidaxomicin was as effective as vancomycin for treating Clostridium difficile diarrhea, a phase III, noninferiority trial showed.
And the new agent resulted in lower rates of recurrence within four weeks of the end of treatment (15.4% versus 25.3%, P=0.005), Thomas Louie, MD, of the University of Calgary in Alberta, and colleagues reported in the Feb. 3 issue of the New England Journal of Medicine.
That "represents an important advance in the treatment of C. difficile infection," according to Herbert DuPont, of the University of Texas School of Public Health in Houston, who noted in an accompanying editorial that efforts should be aimed at reducing recurrence even further.
"The most promising agents for future development should be safe, have low levels of systemic absorption, have low potential for the development of resistance among intestinal and extraintestinal bacteria, provide high levels of active drug in the colon, and be associated with a low rate of recurrence of C. difficile infection after treatment," DuPont wrote.
"Fidaxomicin fits these criteria better than any other agent evaluated so far," he added.
During the past decade, there have been increasing numbers of cases of C. difficile infection, greater morbidity, increased incidence of complications requiring colectomy, and rising mortality rates. C. diff infection is now the most common bacterial cause of diarrhea in the U.S.
Those trends have occurred in conjunction with the emergence of a highly virulent strain, called BI/NAP1/027.
Although infected patients generally respond to vancomycin or metronidazole, the rate of recurrence with these two agents is high -- 20% to 30%.
Louie and his colleagues performed a phase III, randomized, double-blind, noninferiority trial comparing fidaxomicin, a novel agent first in the class of macrocyclic antibiotics, with vancomycin.
They enrolled 629 patients with C. difficile diarrhea from 52 sites in the U.S. and 15 in Canada. About one-third (35.9%) had the BI/NAP1/027 strain.
The patients had 10 days of treatment with either oral fidaxomicin 200 mg twice a day (plus two placebo doses) or oral vancomycin 125 mg four times a day.
Adherence to treatment was high -- greater than 91% -- in both groups. Rates of all adverse events and serious adverse events were similar in the two groups.
The primary endpoint was clinical cure, or a resolution of diarrhea with no need for further therapy as of the second day after the end of treatment.
A similar percentage of patients in each group was cured (88.2% with fidaxomicin versus 85.5% with vancomycin in the modified intention-to-treat analysis).
There were nonsignificant trends toward a faster resolution of diarrhea with fidaxomicin.
Recurrence within four weeks was a secondary endpoint, and was significantly reduced with fidaxomicin in both the intention-to-treat and per-protocol populations.
However, the benefit was not found in patients with the highly virulent BI/NAP1/027 strain (24% recurrence rate with both antibiotics).
In patients with other strains, the infection recurred in 7.8% of patients who received fidaxomicin and 25.5% who received vancomycin (P<0.001).
Louie and his colleagues explained in their paper that fidaxomicin likely reduces recurrence because it kills C. difficile rapidly, whereas vancomycin inhibits the growth of the bacteria.
In addition, they wrote, fidaxomicin has a prolonged post-antibiotic effect against the bacteria that vancomycin does not and does not suppress components of the normal gut flora that vancomycin does.
"The anaerobic bowel flora maintains 'colonization resistance,' which prevents the introduction or persistence of pathogens and may inhibit the reemergence of C. difficile," the researchers wrote. "Preservation of the intestinal flora should also theoretically reduce the likelihood of selection for overgrowth of vancomycin-resistant enterococci."
http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/24661?utm_content=GroupCL&utm_medium=email&impressionId=1296720676434&utm_campaign=DailyHeadlines&utm_source=mSpoke&userid=235671
By Todd Neale, Staff Writer, MedPage Today
Published: February 02, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.
The investigational antibiotic fidaxomicin was as effective as vancomycin for treating Clostridium difficile diarrhea, a phase III, noninferiority trial showed.
And the new agent resulted in lower rates of recurrence within four weeks of the end of treatment (15.4% versus 25.3%, P=0.005), Thomas Louie, MD, of the University of Calgary in Alberta, and colleagues reported in the Feb. 3 issue of the New England Journal of Medicine.
That "represents an important advance in the treatment of C. difficile infection," according to Herbert DuPont, of the University of Texas School of Public Health in Houston, who noted in an accompanying editorial that efforts should be aimed at reducing recurrence even further.
"The most promising agents for future development should be safe, have low levels of systemic absorption, have low potential for the development of resistance among intestinal and extraintestinal bacteria, provide high levels of active drug in the colon, and be associated with a low rate of recurrence of C. difficile infection after treatment," DuPont wrote.
"Fidaxomicin fits these criteria better than any other agent evaluated so far," he added.
During the past decade, there have been increasing numbers of cases of C. difficile infection, greater morbidity, increased incidence of complications requiring colectomy, and rising mortality rates. C. diff infection is now the most common bacterial cause of diarrhea in the U.S.
Those trends have occurred in conjunction with the emergence of a highly virulent strain, called BI/NAP1/027.
Although infected patients generally respond to vancomycin or metronidazole, the rate of recurrence with these two agents is high -- 20% to 30%.
Louie and his colleagues performed a phase III, randomized, double-blind, noninferiority trial comparing fidaxomicin, a novel agent first in the class of macrocyclic antibiotics, with vancomycin.
They enrolled 629 patients with C. difficile diarrhea from 52 sites in the U.S. and 15 in Canada. About one-third (35.9%) had the BI/NAP1/027 strain.
The patients had 10 days of treatment with either oral fidaxomicin 200 mg twice a day (plus two placebo doses) or oral vancomycin 125 mg four times a day.
Adherence to treatment was high -- greater than 91% -- in both groups. Rates of all adverse events and serious adverse events were similar in the two groups.
The primary endpoint was clinical cure, or a resolution of diarrhea with no need for further therapy as of the second day after the end of treatment.
A similar percentage of patients in each group was cured (88.2% with fidaxomicin versus 85.5% with vancomycin in the modified intention-to-treat analysis).
There were nonsignificant trends toward a faster resolution of diarrhea with fidaxomicin.
Recurrence within four weeks was a secondary endpoint, and was significantly reduced with fidaxomicin in both the intention-to-treat and per-protocol populations.
However, the benefit was not found in patients with the highly virulent BI/NAP1/027 strain (24% recurrence rate with both antibiotics).
In patients with other strains, the infection recurred in 7.8% of patients who received fidaxomicin and 25.5% who received vancomycin (P<0.001).
Louie and his colleagues explained in their paper that fidaxomicin likely reduces recurrence because it kills C. difficile rapidly, whereas vancomycin inhibits the growth of the bacteria.
In addition, they wrote, fidaxomicin has a prolonged post-antibiotic effect against the bacteria that vancomycin does not and does not suppress components of the normal gut flora that vancomycin does.
"The anaerobic bowel flora maintains 'colonization resistance,' which prevents the introduction or persistence of pathogens and may inhibit the reemergence of C. difficile," the researchers wrote. "Preservation of the intestinal flora should also theoretically reduce the likelihood of selection for overgrowth of vancomycin-resistant enterococci."
http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/24661?utm_content=GroupCL&utm_medium=email&impressionId=1296720676434&utm_campaign=DailyHeadlines&utm_source=mSpoke&userid=235671
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"Image" problem, yes... but that's the least of its offenses to the senses.
To think all these years I've been flushing good medicine down the toilet...