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.
“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.”
“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.”
“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
“Potential stool donors currently must fill out a questionnaire similar to that of blood donors, and undergo blood and stool tests prior to their donation to "make sure you aren't giving anyone stool that could harm them," McSweeney said.
For example, the first U.S. stool bank, OpenBiome, requires that donors fill out a 200-point clinical questionnaire and take more than two dozen blood and stool screens.
Dr. Colleen Kelley is an assistant professor of gastroenterology with the Warren Alpert Medical School of Brown University, in Providence. "There is a very high bar to be a stool donor," she said. "OpenBiome rejects 97 percent of the donors who apply."
Read more: https://health.usnews.com/health-care/articles/2018-06-05/are-you-a-prospective-poop-donor
“To do something as simple as going in and making a stool donation, and know that it can literally change someone’s life from one day to the next when they have a disease like C. diff, where they can’t even leave their house and the next day they can go about things fairly normally — to see that impact makes me feel good,” he said.”
“At 40 bucks a poop, fecal donors can cash in on their flushings – and improve others' health.
"It's harder to be a stool donor at OpenBiome than it is to be accepted into Harvard or MIT – that's the level of rigor it takes," says Dr. Majdi Osman, an internal medicine physician and the nonprofit's clinical program director. That's because most of the chosen stool will eventually end up in someone else's colon; if it's not carefully screened, the recipient could wind up with any number of medical conditions with potential links to the microbiome.”
Read more: https://health.usnews.com/health-care/patient-advice/articles/2018-05-10/heres-why-people-are-donating-their-poop-to-science
“An important concern relates to the transplanted stools themselves. Majdi Osman is clinical programme director at OpenBiome, the largest stool bank in the USA. ‘We exclude 97% of volunteers’, he told The Lancet Gastroenterology & Hepatology. [...] The vast majority of exclusions occur at the clinical interview. ‘Only physicians can collect the material, and we vet all the centres who apply to make sure that they have the facilities to administer it safely’, adds Osman.”
“On daigne à peine les regarder, encore moins les sentir. Nos excréments sont sans conteste l’un des plus grands tabous de notre société aseptisée. Pourtant, malgré le dégoût qu’ils inspirent, ils sont précieux.
Leur valeur? Quarante dollars pièce, précisément. Du moins dans le Massachusetts, aux États-Unis, où OpenBiome achète cet or brun depuis 2012 auprès de donneurs triés sur le volet. Cet organisme à but non lucratif est la plus grande banque de selles au monde. Sa mission : sauver des vies avec des matières fécales.
“Car celles-ci recèlent une richesse insoupçonnée, une armée de « bonnes » bactéries qui ont le potentiel de rééquilibrer les flores intestinales mal en point. En 2017, OpenBiome a ainsi expédié des fioles de selles filtrées dans près de 1 000 centres médicaux aux 4 coins des États-Unis, où ont été prodigués plus de 10 000 traitements.”
"OpenBiome is changing lives thanks to the increasing evidence of the crucial impact of gut health and the microbiome on our overall health – with potential applications in a range of areas, from Parkinson’s to mental health. The company is pioneering research in this field, currently supporting 14 clinical trials.
We wanted to get to the bottom of this fascinating new medicine, so we caught up with founder Mark Smith to get down and dirty on stool banks, fecal transplants, and how this research is revolutionising medicine."
With its 2.8 percent acceptance rate, OpenBiome is almost twice as selective as Harvard College. You might make it through the initial evaluation—a short survey, a 200-question form, and a clinical visit—safe in the belief that your poop is a solid 10, but you might find out through the subsequent blood and stool analyses that your bacteria could harm, not help, the recipient.
Adam Reiley of WGBH News visited OpenBiome to discuss fecal transplants, the challenges of treating recurrent C. difficile, and our new stool donor recruitment campaign.
For years, medical science was powerless against one of the most of severe intestinal infections. But a new treatment shows tremendous promise -- if patients aren't too squeamish to try it.
Fecal transplants use the stool from a healthy person to repopulate life-sustaining bacteria in the colon of the patient. This technique is so effective that researchers are testing its potential to treat disorders far beyond the digestive tract, pointing to breakthrough treatments for a broad range of the most stubborn diseases.
"Surgeon Gabriel Weston travelled to Rhode Island in the US to watch Dr Colleen Kelly perform a faecal transplant — a procedure that has a 90% success rate when used to treat the life-threatening bacterial infection Clostridium difficile.
It is vital that the poo being used in the transplant is properly screened for infections and disease and it’s actually much harder to be a poo donor than you might think. At Open Biome in Boston, a non-profit company that provides screened, filtered and frozen poo for clinical use, only 6% of potential donors make it through the rigorous testing programme."
"It's harder to become a donor than it is to get into MIT," joked co-founder Mark Smith (who would know, as he got his PhD in microbiology there). Of the 1,000 or so potential donors who've expressed interest on his Web site over the past two years, only about 4 percent have passed the extensive medical questioning and stool testing.
The screening process can cost up to $5,000 -- so when someone makes it through, Smith and his co-founders hold on tight.
"We get most of our donors to come in three or four times a week, which is pretty awesome," Smith said. "You're usually helping three or four patients out with each sample, and we keep track of that and let you know."