"A paper today in Science calls for a better way to regulate an increasingly popular method of treating recurrent Clostridium difficile infection (CDI).
The method, known as fecal microbiota transplantation (FMT), involves the transfer of stool from a healthy donor—via colonoscopy, nasogastric tube, or enema—into the colon of a patient who has recurrent CDI to re-introduce healthy bacteria into the gut. While still an investigational treatment, FMT has produced strong results in several small clinical trials in recent years, with cure rates as high as 90%.
A growing number of physicians are turning to it as an alternative to antibiotics—which can contribute to re-infection by wiping out the beneficial gut bacteria that keep C difficile bacteria in check—and several medical societies have said it should be a standard of care for patients with multiply recurrent CDI.
But proponents of FMT are concerned that the unsettled regulatory landscape may be preventing the procedure from being more widely accessible."
“'The way the regulations are written now, everything is being done under enforcement discretion,' says Diane Hoffman, a professor of health law at the University of Maryland, and first author on the Science paper. The FDA is just choosing to bend the rules for C. diff. patients. But the agency could just as easily unbend them, whenever it wants. Which is why Hoffman and her colleagues are suggesting transplants used for C. diff be regulated as a 'practice of medicine' rather than a drug, when the stool comes from someone the patient or physician knows, i.e. not a stool bank. Then it would only be subject to state, rather than federal regulation. More patients could then access the treatment—which has cure rates above 80 percent—regardless of market winds or agency whims. All other uses of FMT would still be subject to formal clinical trials overseen by the FDA."
“If you had wanted to be a feces donor for a certain major hospital system before February 2016, you would have had to buy yourself a blender.
On the morning of the transplant, you would have woken up, produced a bit of fresh dung, and blended it with salt water until it had what the hospital described as “a milk-shake-like consistency.” You would have put the slurry in a Ziploc, carried it to the hospital, and — after some futzing — it would have been deposited into the gastrointestinal tract of a family member or friend.
In some ways, the field has come a long way since those DIY days of freezer bags and blenders.”
"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."
“In a study by Cryan and colleagues, a fecal microbiota transplantation from depressed human patients to GF rats resulted in behavioral and physiological symptoms of depression in the animals. “In effect, we were able to transfer the blues,” says Cryan. “Experiments like this are helping us move away from just describing changes and toward causative effects.”
The animal evidence seems promising, but translating this treatment to humans is still in the very early stages. OpenBiome, a nonprofit stool bank based in Cambridge, Massachusetts, is planning the first trials of fecal microbiota transplants for depressed patients. “We will try to select a donor that would complement the deficiency or replenish those bacterial communities that are depleted in patients with depression,” says Shrish Budree, senior clinical research scientist at OpenBiome (Figure 4, right). “One great aspect of OpenBiome is that we highly characterize all our stool donors,” Burdree notes. “They go through a rigorous clinical and serological screening, and we also genetically sequence all our donors so we know the exact microbial composition of their stool. If we know that certain bacterial communities are abnormal in a recipient, we can select a donor who is enriched in those bacteria.”
"It’s one of the most exciting areas of science right now, the microbiome. Trillions of organisms define your own unique makeup, and a large portion of these microbes is found in the gut, which forms an integral part of your immune system. This area, if tweaked, has the ability to transform your health. The race is now on in biomedicine to help deliver a new wave of treatment based on this area. One of those startups spearheading research and interest in this is OpenBiome, founded by Mark Smith and James Burgess, a startup based out of Massachusetts dedicated to expanding safe access to fecal microbiota transplantation (FMT) through its public stool bank and catalyzing research into the human microbiome."
"So, are we so obsessed with being clean that we're making ourselves sick? The science says yes:
Germs and bacteria are misunderstood.
Some bacteria are bad, but most help us maintain a healthy balance in the microbiome.
In our quest to kill germs, we have traded infectious diseases for chronic ones that are very hard to treat. And that’s why we’re turning to therapies like the fecal transplant.
The concept behind the poop transplant is very basic. A donor, who’s been through a rigorous screening process, provides a stool sample that’s loaded with his or her naturally healthy bacteria. It's then implanted into the patient who has a bacterial disease.
"Fecal transplants have the power to revolutionize medicine, but hospitals need raw materials. At Open Biome, the country’s first independent stool bank right outside Boston, donors earn $40 for each sample. The clinic, however, approves less than 3 percent of applicants. VICE correspondent Thomas Morton visited the stool bank and made a deposit."
Click here to watch the video.
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.
NBC Boston visited with a patient who received FMT from OpenBiome at the Brigham & Women's Hospital in Boston, and then came by our lab to talk about how to manufacture stool treatments. Watch the video at NBC Boston.
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.
In an op-ed in the Huffington Post, Catherine Duff, founding president of the Fecal Transplant Foundation and Carolyn Edelstein, director of outreach and public affairs at OpenBiome, reflect on OpenBiome's announcement of its collaboration with Finch Therapeutics and on how an FDA-approved microbiota treatment for recurrent C. difficile infection would transform patient care.
View the op-ed here.
Mark Smith, 29
Smith's company, OpenBiome, developed a therapy called fecal microbiota transplantation to treat Clostridium difficile, a common hospital-acquired infection. Like a blood bank for human stool, the nonprofit's work has helped over 18,000 patients.
Click here for the full profile.