Posts Tagged ‘fecal transplant’


An infection with a drug-resistant strain of E. coli proved fatal for a man who received a fecal transplant.

The first person known to die as a result of a fecal transplant is a 73-year-old man who developed a fatal infection with antibiotic-resistant bacteria that were in the donor’s stool sample.

News of the man’s death surfaced in June; he was one of two patients in separate clinical trials who became ill after receiving fecal transplants from the same donor.

Both patients developed infections with a strain of Escherichia coli, or E. coli, that demonstrated resistance to different types of antibiotics. Details of the man’s death were described in a new study published online Oct. 30 in The New England Journal of Medicine.

The two patients, who were participants in clinical trials conducted at Massachusetts General Hospital (MGH), received fecal transplants in the form of pills that were made in November 2018.

Fecal microbiota transplantation (FMT) — commonly known as a “poop transplant” or fecal transplant — is emerging as an effective experimental treatment for Clostridium difficile, or C. diff, a potentially life-threatening bacterial gut infection. In guts with depleted microbial diversity, poop transplants boost diversity with microbial infusions from a healthy person’s gut microbiome, distilled from stool samples and delivered as an enema or an oral pill.

But FMT is also being tested as a method of restoring gut microbial diversity for conditions not caused by C. diff. The two clinical trials at MGH were testing the impact of FMT on microbiome issues associated with liver disease and the effectiveness of preventive FMT prior to stem cell transplants.

Eight days after the 73-year-old patient received his last FMT dose, he developed a fever and chills, and exhibited “altered mental status,” according to the study. His condition quickly worsened. The man developed sepsis — an extreme immune response to infection causing inflammation throughout the body and organ damage — and died two days later, with evidence of an antibiotic-resistant strain of E. coli in his blood.

The other patient who became ill from the FMT, a 69-year-old man, also tested positive for the drug-resistant strain of E. coli. However, his infection responded to treatment with antibiotics. Eventually, he was pronounced “clinically stable,” the researchers wrote in the study.

Antibiotic resistance in harmful bacteria is a growing concern worldwide. With the emergence of these so-called superbugs — some of which can share their resistance with other bacteria — entire classes of antibiotics are becoming less effective at quelling infections, and health practitioners are losing key weapons in their disease-fighting arsenals.

High-risk patients

In January 2019, a regulatory review by the U.S. Food and Drug Administration (FDA) dictated that stool samples for FMT had to be screened for drug-resistant microbes. But as this E. coli strain is rare in healthy people, the pills that were produced in November were not tested retroactively, the study authors reported.

Both of the FMT-sickened patients were considered at high risk for bacterial infection because of conditions that weakened their immune systems. The man who recovered had advanced cirrhosis — severe scarring of the liver — and the man who died had recently undergone a stem cell transplant and was taking immunosuppressing drugs so that the transplant would not be rejected, the scientists reported. Samples from the same donor were administered to 22 patients in all, and although several other recipients tested positive for the resistant E. coli, the bacteria didn’t make them ill.

On Nov. 4, FDA officials will conduct a 7-hour public hearing at the agency’s Silver Spring, Maryland, campus, “to obtain public input on the state of the science regarding FMT to treat C. difficile infection not responsive to standard therapies,” according to a notice on the FDA website.

The FDA hearing will also review clinical evidence to evaluate the effectiveness and risks of using FMT to combat persistent C. difficile “and to better understand the impact of FDA’s enforcement policy on product development,” agency officials said in the statement.

https://www.livescience.com/fecal-transplant-death.html?utm_source=Selligent&utm_medium=email&utm_campaign=9583&utm_content=20191101_LS_Essentials_Newsletter+-+adhoc+&utm_term=3675605&m_i=uxOuCb14GZ_f_Gtk%2Bp9nsep0qM1OWDMFvl255HddfzLlp4atZ49G7gBQyO3IdDiaYEBisgwkAznzqIBplBPr0oSWQdXtA95quF

BY Erika Engelhaupt

A new nonprofit called OpenBiome is hoping to do for fecal transplants what blood banks have done for transfusions. It’s a kind of Brown Cross.

And it’s an idea whose time has come. Recent trials testing transplants of fecal microbes from the healthy to the sick have been so promising that people are attempting dangerous do-it-yourself fecal transplants by enema, for lack of access to authorized medical procedures.

Graduate students Carolyn Edelstein and Mark B. Smith got the idea for OpenBiome after a friend had trouble getting a fecal transplant to treat an infection with Clostridium difficile. The bacterium causes dangerous, even fatal, diarrhea and in an increasing number of cases is resistant to antibiotics.

People tend to get C. difficile infections after antibiotics or chemotherapy has knocked out helpful bacteria, allowing what is normally a background player to take over. Transplants of fecal bacteria from healthy donors can help reset the microbiome, the mix of bacteria in the body, and crowd out C. difficile. A 2011 review of 317 patients treated for C. difficile found that fecal transplants cleared up infections in 92 percent of patients. And more recent research showed that taking a round of pills containing bacteria isolated from fecal matter (without the feces itself) resolved C. difficile infections in all of 32 patients treated.

There’s also interest in transplanting healthy fecal microbiomes into people with inflammatory bowel disease or even obesity. In one recent test, mice implanted with fecal microbes from thin humans stayed thin, while mice given bacteria from obese people gained weight.

But the transplants are hard to get. As Edelstein and Smith’s friend learned, the U.S. Food and Drug Administration requires lots of paperwork for the experimental therapy, and donor feces has to be screened for a host of potential pathogens.

That’s where OpenBiome steps in. The nonprofit offers hospitals fecal samples for $250 that have been prescreened to ensure they are free of pathogens and parasites. Since October, they’ve sent more than 100 samples to a dozen hospitals and clinics, according to an interview with Smith in the Chronicle of Higher Education. Edelstein, who’s studying public affairs at Princeton, and Smith, who’s studying microbiology at MIT, recruited friends and donors and negotiated permissions with the FDA to set up the organization, which houses its samples at MIT. OpenBiome is also offering to collaborate with researchers for long-term follow-up on patients’ microbiomes.

Because FDA considers feces to be a drug in the context of transplants, OpenBiome is providing stool only for treatment of C. difficile. People hoping to shift their microbiomes for other purposes are still out of luck. Until more testing and approval comes through, that leaves open the risk that some people may resort to home transplants.

Let me be very clear about this: Whipping up an enema of your friend’s stool is a terrible idea.There are excellent reasons why people normally avoid poop: It can carry pathogens and parasites that cause serious disease. Even a donor who appears perfectly healthy might be carrying around bacteria or viruses that his or her immune system or particular microbiome mix is able to deal with. Your mileage may vary.

Your genetics, your immune system, your diet and environment — all these things create the ecology of your insides, making it hard to predict what your outcome might be. What’s more, you may need to make other medically supervised changes along with the transplant. Research on microbiome links to obesity, for instance, suggests that a new “skinny” microbiome has to be accompanied by a switch to a diet lower in fat and calories, or else the new microbes will just be outcompeted.

These dangers and complicating factors are why a supply of prescreened stool is so important. The procedures need to be done under medical supervision, and when done right the results look really promising. The recently tested pill approach avoids some of the yuck factor of fecal transplants, but most transplants are done via an enema, colonoscopy or nose tube to the gut.

If you get transplant material from OpenBiome, you’ll have to submit to one of the usual transplant methods rather than a pill, but you can rest assured you’re getting high-quality stuff. Not only are the samples screened, the donors are among the best and brightest: a few young researchers and scientists from Harvard and MIT.

https://www.sciencenews.org/blog/gory-details/introducing-first-bank-feces?mc_cid=325756381e&mc_eid=9da0429978

Thanks to Jody Troupe for bringing this to the attention of the It’s Interesting community.