Strict quality control and screening should be an essential part of the FMT procedure, as an increase in serious adverse events in the context of investigational FMT could lead to harder regulations and make access more difficult for patients, which would likely increase the demand for unregulated or ‘at-home’ FMT. However, obtaining safe stool for faecal transplantation is not trivial. In the US, a not-for-profit stool bank, OpenBiome (http://bit.ly/30nsE1B), was founded in 2012 and now supplies stool for most of the US investigational FTM procedures. Stool donors are selected through strict health screens and are closely monitored; additionally, samples are sequenced to screen for pathogens and to determine their composition, and then quarantined to ensure they were not obtained during the seroconversion period of an infectious disease. Aliquots of every stool preparation are kept for future reference in case of an adverse event.
“Last month the Food and Drug Administration sent out an emergency alert: Two people who had undergone fecal transplants developed multi-drug-resistant infections from bacteria in the stool they were given, and one died.
The death and illness may be the first serious adverse events associated with the poopy procedure, out of tens of thou sands of times it's believed to have been performed in the US. If those numbers are accurate, that’s an awfully good safety record. But it’s hard to know for sure, because roughly a decade since the procedure became mainstream, it still occupies a legal gray area, and thus whatever data is being collected isn’t comprehensive or public. …
“The material in these cases did not come from OpenBiome,” says Majdi Osman, a physician and the clinical program director at the stool bank, which screens for health risks so thoroughly that it boasts of excluding more than 97 percent of potential donors.
It seems likely the first effect of the patient’s death will be new requirements for thorough donor screening at any place performing transplants. That isn’t yet universal because the relevant professional societies, which typically write such detailed standards, haven’t tackled fecal transplants so far. But in a follow-up to the announcement of the death, the FDA said it will require the places performing poop transplants not only to check donations for pathogens, but to question donors about their daily-life risks of exposure to bad bugs.”
“If the idea of fecal transplants seems momentarily disquieting, consider that they achieve a 90 percent cure rate for the devastating intestinal infection known as C. diff when antibiotics fail to clear it. Fecal transplants are also being studied as treatment for colitis, Crohn’s disease, and other inflammatory gastrointestinal disorders, and research into their value for urinary tract infections and even Parkinson’s disease is underway. By transferring stool in sterile conditions from a donor to the intestines of someone who is ailing, fecal transplants are designed to introduce a healthy mix of gut bacteria into the body and restore bacterial balance. What’s that good for?”
Watch the panel discussion here.
“Fecal microbiota transplantation (FMT) is the transfer of feces from a healthy donor into the colon of someone who's sick, explains Scott Olesen, PhD, scientific director at OpenBiome, a nonprofit stool bank that conducts research and works with clinicians to facilitate FMT. Specifically, we know that FMT can be helpful in treating C.Diff, a serious and sometimes fatal gut infection caused by bacteria. The belief is that FMT can help "re-shape the environment of the gut," he says. In clinical trials, FMT has been shown to resolve 80-90% of recurrent C.Diff, and that's major.”
“In den USA ist das anders: Es gibt richtige Stuhlbanken. Die größte von ihnen ist die nahe Boston angesiedelte Non-Profit-Organisation OpenBiome. Sie wurde 2012 von Studierenden des Massachusetts Institute of Technology gegründet. Ärzt*innen können von der Stuhlbank sicheren Stuhl beziehen. OpenBiome arbeitet zu jeder Zeit mit 30 bis 40 Spender*innen. Weniger als drei Prozent der Bewerber*innen werden angenommen, erzählt Majdi Osman, Mitglied des Führungsteams. Wer es schafft, kann schon morgens vor dem ersten Kaffee Leben retten und sich per Stuhlgang 40 Dollar dazuverdienen.
Die Organisation wirbt mit Bildern, auf denen Menschen mit Superhelden-Umhang neben einer Toilette posieren. „Mach deine Morgenroutine heroisch“, steht darüber. „Die Leute integrieren das Spenden in ihren Alltag. Sie kommen etwa immer auf dem Weg zur Arbeit oder in der Mittagspause vorbei“, sagt Osman. Bei OpenBiome versuchen sie, die Situation, die dann folgt, durch Humor weniger komisch zu machen. Die Situation, wenn Spender*innen ihren in Plastik verpackten Kot über einen Theke reichen.”
“The Boston area is the epicenter of a debate dividing the medical community.
The argument? How human feces should be regulated.
That's right — fecal transplanting is the process of transferring poop from a healthy donor to a sick patient. And it's proven effective for treating certain infections.
But some doctors and patient advocates are concerned that the Food and Drug Administration is about to clamp down on this radical therapy.”
listen more to the full segment here: https://www.wbur.org/radioboston/2019/04/12/human-feces-fda-restrict
“To be a fecal matter donor in the first place you already need to have a superior gut. At OpenBiome, the sole U.S. stool bank that provides samples for most of the transplants, requirements include the obvious: no family history of inflammatory bowel disease or colon cancer, no frequent stomach issues like bloating, constipation, or diarrhea, and no recent antibiotic use. But they also screen for autoimmune and mental health conditions like depression, anxiety, asthma, and allergies, which have all been potentially linked to the microbiome.
“Our donors, they go through a pretty rigorous screening process; overall the pass rate is just under 3 percent,” says Majdi Osman, the clinical program director at OpenBiome. “We always joke here that it's harder to become a stool donor at OpenBiome than it is to get into Harvard.”
Right now, beyond the rigorous health screen, scientists aren’t exactly sure what they’re looking for in a donor, which makes identifying super stool difficult. No one strain of bacteria ensures a healthy gut. In fact, entire families of bacteria are present in one seemingly healthy person and absent in another. The only thing that healthy guts seem to all have in common is diversity—the more bacterial strains, the better.”
“Depuis, la transplantation de micro-biote fécal (TMF) a fait ses preuves. En 2013, des chercheurs néerlandais publient les résultats d'un essai clinique qui fera date : ils mesurent un taux d'efficacité supérieur à 80 % chez les patients greffés, contre 23 à 31 % seulement chez ceux sous antibiotiques. "C'était si efficace que l'essai a été arrêté prématurément : il n'était pas éthique de poursuivre le traitement standard alors qu'il y avait une alternative bien supérieure" , raconte Harry Sokol, gastro-entérologue à l'hôpital Saint-Antoine (Paris) et président du Groupe français de transplantation fécale. Confirmée par d'autres essais, la formidable efficacité du changement de microbiote a poussé les sociétés américaine et européenne de gastro-entérologie à le recommander pour le traitement des infections multirécidi-vantes à C. difficile . "C'est un traitement écologique pour une maladie écologique : on remplace simplement un écosystème perturbé par un écosystème non-perturbé" , explique le spécialiste Joël Doré, à l'Inra.”
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“For now, most of the material used in fecal transplants comes from OpenBiome, the public stool bank in Cambridge that embraces its mission with both humor and gravitas. Giant poop emojis decorate its offices, conference rooms are named after sections of the intestinal tract and employee birthday cakes invariably come in one flavor: chocolate.
The organization produces 900 to 1,000 monthly treatments, most of them bottled liquids that are packed in dry ice and sent overnight to clinics across the country. Any unpleasant odors are confined to an airtight production facility, where employees in white hazmat suits gingerly handle clear plastic bags filled with a mud-colored slurry.
The material comes from donors who earn $40 a pop and must pass intensive screenings and regular medical checkups. “It’s harder to become a stool donor than it is to get into M.I.T.,” said Carolyn Edelstein, who runs the organization.
In 2012, Ms. Edelstein created OpenBiome with Dr. Smith, now her fiancé, after her cousin contracted recurrent C. diff and, facing a six-month wait for the procedure, did it at home with a roommate’s stool.
A few months later they started OpenBiome with seed money from a foundation and sent out six treatments that first year. “It’s been a wild ride,” Ms. Edelstein said as she showed off a room full of mammoth freezers that hold thousands of screened stool samples.
But OpenBiome and other stool banks are facing an uncertain future. Drug companies, which have been struggling to funnel patients into the clinical studies that are required for F.D.A. approval, would like federal officials to restrict the stool bank’s ability to distribute fecal matter in the hope that more patients will enroll in their trials.
The F.D.A. has ramped up oversight of OpenBiome’s production, leading to more rigorous testing and higher prices, which will double to $1,600 this month.
Patient advocates expect those prices to jump exponentially should the F.D.A. grant market exclusivity to one of the companies that are in the final stages of testing alternatives to raw stool transplants.”
“Donating poo isn't like giving blood. Carolyn Edelstein, head of stool donation company OpenBiome, told the New York Times in 2018, "Only about three percent make it through our screening process. We like to joke with our donors that it's easier to get into Harvard or M.I.T. than be a stool donor." It's very important for the gut microbiome of donors to be just right, without anything that might cause havoc when introduced into a sick person's colon. And for that reason, screening is very intensive — but can be very fruitful."
A study published in Frontiers in Cellular and Infection Microbiology on Jan. 21 found that some people are "super poopers," and that their poop donations could help people sick with C. diff, diabetes, or IBS, Jackie Flynn Mogensen writing for Mother Jones reports. It's not clear what would make a "super" donor, but having a very diverse range of bacteria in the gut seems to help.”
“Donating your feces to a local hospital or nonprofit could be one way to help—and it could be lucrative. One Boston-based nonprofit, OpenBiome, pays $40 per stool donation. (But before you whip out a plastic baggie and mail your poop in, you should know that OpenBiome only works with donors in the Boston area and, due to an abundance of safety precaution, typically accepts less than 3 percent of applicants, making the screening process more selective than getting into Harvard.)
The group works with more than 1,000 hospitals across the country and has sent treatments to about 40,000 patients, mostly with C. difficile.”
“Clostridium difficile infection is the most common hospital acquired gut infection, and our interest in the disease came after reading a scientific paper that showed fecal transplants work were effective even in cases where standard antibiotic therapy had failed. Patients, however, could not get access to treatment at that time, because doctors didn’t have access to the material for fecal transplants. We knew how to do it in the lab, and in 2013, my graduate student Mark Smith started a non-profit stool bank called OpenBiome, and we treated our first patient later that year. We’ve treated about 40,000 people so far. We’re partnering with over 1,000 hospital networks across the U.S. to make sure everyone has safe access to this medical procedure.”
“There's evidence that when someone has a food allergy, gut bacteria send the wrong message about what the body should tolerate.
‘We looked at babies who were allergic and babies who were not allergic and we analyzed their microbiota and we found significant differences between the babies that were allergic and the babies that were not allergic,’ said Dr. Rachid.
The thought is by transplanting another person's healthy gut bacteria into someone with an allergy, the microbiome can be repaired and send healthy signals to the immune system to tolerate allergens like peanuts.”
“How does the gut microbiome help with patients’ receptivity to immunotherapy? What key factors influence it and what strategies offer the opportunity to shape it and augment therapeutic response?”
Watch the video below:
“Are we too clean? Germ theory and hand washing saved millions of lives, but has the pendulum swung too far in the opposite direction? We talk about everything from regular soap versus anti-bacterial, our microbiome and the role of probiotics, the hygiene hypothesis and the rise of auto-immune diseases, and explore both fecal transplants and helminthic therapy.”
Watch the episode here!
“The THRIVE (transfer of healthy gut flora for restoration of intestinal microbiota via enema) trial is a small phase 1 study that will investigate whether faecal transplants can help severely malnourished children who fail to develop even after their nutritional needs are met.
Globally, about 35% of children who have severe acute malnutrition fail standard therapy, which includes specially formulated high-calorie food, says UCT’s Shrish Budree, a research fellow at OpenBiome and one of the investigators on the trial.
‘These kids don’t achieve their full growth potential and end up stunted, with an increased risk of infections and mortality,’ he says.
‘In the longer term, they are likely to be less productive adults, which has bigger implications for society at large. There is currently no alternative for the kids who don’t respond to standard therapy.’”
"For physicians and researchers involved in the Cape Town trial, dubbed Thrive, healthy faecal matter is like gold. They believe it could be a fix for the 40% of severely malnourished children who do not respond fully to nutritional feeding.
SA will be the first country on the continent to test if such transfers can prevent stunting from malnutrition, which impairs mental development and dramatically increases child mortality rates. Malnutrition is common in SA and affects 19-million children globally."
“Tausende Arten von Mikroben besiedeln den Menschen. Jetzt erkunden Forscher dieses gigantische Arsenal – und entwickeln neuartige Arzneien gegen Durchfall, Entzündungen und Krebs.”
Read more here.
“Screening donors on an individual basis is not only expensive—it is also not for the squeamish. Carolyn Edelstein is the executive director of OpenBiome, the first stool bank, which operates in the Boston area and provides physicians and researchers with prescreened fecal matter. Before stool banks existed, Edelstein says, physicians had “shelves and shelves of blenders” in which, if they got as far as finding and screening a donor and acquiring a sample, they would need to puree the donation so it could be siphoned through a colonoscopy tube. The blenders had to be thrown away afterward, as they could not be properly sterilized. It was not a sideline most doctors found alluring.
The 2014 FDA guidelines provided no role for—or regulation of—such organizations. “Limiting donations to people the patient or physician knows would eliminate the possibility of using a stool bank,” says Hoffmann. The guidance was updated in 2016, allowing physicians to use a hospital stool bank, but even then the stool sample had to be obtained under the direction of the treating physician.”
“Fecal transplant donor profile does not appear to impact clinical outcomes in the treatment of Clostridium difficile infection, according to research presented at Digestive Disease Week.
Shrish Budree, MD, of OpenBiome and the University of Cape Town, South Africa, said success of fecal microbiota transplantation in the treatment of CDI is more likely due to other factors, such as clinical practice and accurate diagnosis.”
read more: https://www.healio.com/gastroenterology/infection/news/online/%7B1c576cad-a8ce-46e9-89d2-f7c159327ce7%7D/fecal-transplant-outcomes-not-impacted-by-donor-profile