Clostridium difficile causes diarrhea and can be fatal, but a poop enema may help kick the infection. Swallowing poop might sound like a fast-track to sickness, but when prepared properly and delivered in the right way, human feces can actually have a beneficial effect on our health. Now, in a world first for fecal transplants, a company in Australia has been given the go-ahead to syringe a treatment derived from a donor's stool into a recipient's colon as a way of kicking a certain type of bowel infection. Clostridium difficile, often referred to as C. diff, is a type of bacterium that causes diarrhea and inflammation of the colon, a condition known as colitis. It’s an infectious condition that mostly affects people who are taking antibiotics for something else, which is one of many arguments for only using antibiotics when directed to do so by a doctor. You’re actually 7 to 10 times more likely to get C. diff while on antibiotics and during the month after taking them because as well as killing off germs that make us sick, they can also wipe out the good bacteria that keep us healthy. Where poop pills and fecal transplants come into the equation is in the restorative power someone else’s feces can have on your gut microbiome. If your gut has been stripped of its good bacteria through medication, swallowing a properly prepared feces sample from a healthy donor, or having it inserted into your colon, can help to repopulate your microbiome with the good guys. This world-first approval for fecal transplants has been granted to BiomeBank by Australia's Therapeutic Goods Administration (TGA). It gives BiomeBank the go ahead for a “microbiome-based therapy product”, or BIOMICTRA for short, to treat C. diff infections that could otherwise be fatal. BiomeBanks’s approach involves putting a formula derived from donor poop samples and freezing it in a syringe, which can then be used to deliver a colonic enema containing microbiome-boosting germs during a colonoscopy. This is the only delivery method so far to receive the TGA’s approval (though they are working on a pill version to be swallowed), and – as their chief technology officer Sam Forster told The Guardian – it comes with several benefits. "The advantage of delivering during a scope is that you can get a large amount there very quickly. If you took it as a pill or a capsule, it would have to pass through the upper gastrointestinal tract to get to where it wants to live. You definitely don’t want a chewable tablet." "Your problem is the volume – if you’re trying to put a few hundred milliliters [around 10 oz] of fecal material … that’s probably a normal glass size. You wouldn’t want to deliver it that way." The transplants come from “super donors”, sometimes called “unicorns”, who deliver the goods in special toilets. Incase you’re wondering what qualifies someone as a super donor for poop transplants, a 2021 paper discusses at length who makes the best candidates, and why it’s worth abandoning the “One Stool Fits All” approach, which – apparently – was a thing. If you’re thinking that using fecal transplants as medicine isn’t a world-first, then you’re right, but what makes the TGA’s approval noteworthy is that it’s the first ever regulatory approval for a donor-derived microbiome drug product. In the USA, explained New Atlas, the US Food and Drug Administration will allow you to opt for a fecal transplant if you can source your own donor, but if it goes wrong, you’re on your own. The landmark approval is big news for the use of microbiome therapeutics worldwide and is one BiomeBank hope will help to improve the lives of some people living with debilitating disease. “We are excited to progress the development of our cultured microbiome based therapies with the aim of alleviating microbiome mediated disease on a much larger scale,” said BiomeBank’s co-founder and managing director Dr Sam Costello in a statement. “It’s an exciting time for the microbiome field and we are pleased to be pioneering new solutions to treat these diseases.” Source
