 Speaking, Stacey is the assistant professor of pediatric gastroenterology and hepatology nutrition here at the University of Chicago, where she directs the translational IBD clinic, and she will be talking on ethical issues in fecal microbiota transplantation. Great. Thank you. Yeah. So, we're going to change directions. We've had a really nice array of discussions about organ transplant, and I'm going to talk to you today about the microbiome, which many feel is an organ, and give you a little bit of background about this innovative form of transplantation. So for some disclosures and disclaimers, I have no relevant disclosures, and you all should know that fecal microbiota transplantation is considered an investigational therapy in the United States, and the use of fecal transplant for clinical indications other than claustridium difficile or C. diff infection, or for the use of research purposes, requires FDA approval and an investigational new drug application, and if anybody is interested in that, I'm more than happy to share some information about the process, but time does not allow today. So a little bit of background about the human microbiome. The microbiome is the bacteria in and on our bodies, and we now understand that the microbiome contains trillions of the microbes with which we coexist. We can't live without them. In fact, they outnumber our human cells by at least 10 to 1, and although the data vary, it appears that they may constitute at least 500 grams in an adult human. So as I started, I sort of introduced the idea that many in the field feel that the microbiome is an organ. According to the definition of an organ, it can be identified and distinguished from other types of cells and tissues. It consists of a large group of cells performing specific functions that are very, very specialized, and it's necessary for maintaining health. And although by all of those criteria, it fits the definition of an organ, the FDA has determined that it is a more analogous to a biologic tissue. Nonetheless, we do know that regardless of whether it's an organ or a tissue, it can actually be transplanted, whole or in part. And in this transplant, it can be used to treat or cure specific diseases. And as shown by the machine, large contraption in this image, it can be purified, it can be modified, it can be extracted or encapsulated. And more recently, we've been shown that we can even create a synthetic form of stool that contains microbiome within it. So let's move on to talk a little bit about fecal microbiota transplantation. It has a variety of different names. It's known as fecal bacteria therapy, stool transplant, and is often the subject of many interesting jokes. Nonetheless, it is the delivery of an entire microbial community from a healthy individual to an individual with a disease. It involves the identification of a healthy donor. And we have many questions about who is a healthy donor, and that is still up for debate. That donor must go through an extensive medical and social screening. In fact, the criteria for donating stool are far more rigorous and personal than that for donating blood or other organs. That donor then goes through extensive screening for infections, both in the blood and the stool, with a very rigorous protocol. The fecal matter is then collected and prepared, and then can be delivered by enema, colonoscopy, upper endoscopy, or nasogastric tube. So probably some of you, at least many of you, have heard about fecal transplants. They certainly have been talked about extensively in the media, from the Huffington Post, in the New York Times. Everybody likes the quick quip in the title of their article. It's great source for getting people interested in the topic. And in fact, we have been very lucky that we've been involved in some of the very first fecal transplants for children with recurrent and relapsing C. diff. And here you can see the reference to the original case we performed. In an 18 month old, who had had C. diff for more than half of his life and on continuous antibiotics, he actually had had seven episodes of relapsing infection. So putting this in the context of other transplantations, we know a lot about the history of transplants at the University of Chicago and the evolution of transplant and transplant ethics. So this timeline sort of puts it all into perspective. As you can see, we have reports of the skin transplants as early as 1869, moving along the cornea, twin kidney donations. And then you can see I've highlighted the first reported use of fecal transplants, or FMT, for Pseudomembranus colitis, which is an infectious complication of the C. difficile. And then later in the 1980s, it was used for inflammatory bowel disease. And then of course, now we have much more, many more types of transplantation, living donors, full face, and possibly uterus, as we heard today. But actually, transplant of stool is probably the oldest form of transplantation. So I wanted to highlight some of these particularly interesting ethical and social issues related to FMT. So we always need to think about how we balance innovation, investigation, and patient safety as we explore these new potential therapies and new forms of transplantation. And of course, in that, we have to know how we're going to discuss risk, which becomes incredibly complicated when we don't have a really good way of quantifying the risk from these novel forms of transplant. And we furthermore, we have no idea how FMT might affect future health risk, as I just mentioned. We also need to determine who might be eligible for FMT, who should pay for it, does it depend on the condition, does it depend on the insurance, the age of the patient. And of course, as many people are familiar, there's quite the stigma and the yuck factor and what type of impact that might have on patients' donors and those involved with this. There are also a number of questions that relate to the donor specifically. And as I mentioned before, how do we decide who's a healthy donor? And how do we define health? Should our donors be related or unrelated? Does it matter what the disease is or the condition? Should we choose parents or children or siblings? All of these questions need to be answered. Should we treat it like an organ transplantation, even though it's not traditional organ in the sense of a solid organ as we've heard about today? And should we take in consideration that although many people think of the donation of stool as a very low risk procedure, there's still no easy opt out for family members. And how are we going to protect our donors to make sure those who might be uncomfortable or have other reasons for not wanting to donate are given an easy way to not be coerced into this? And that they perceived it over traditional Western medicines due to known side effects. They want it now. Some were even frustrated that it wasn't already available. And that in general, from these focus groups, that they preferred family members to be the donors and that they would still need screening. And I just want addition to have this treatment and this transplant regardless of how severe their disease was. They cited that the reasons they wanted FMT were the effectiveness, that it was safer compared to other therapies and that they wanted to avoid surgery. So clearly some of the rationale was valid, but we really don't have the efficacy or safety data yet. So it's concerning that some of the patients perceived the safety on this transplant is quite high already. They preferred colonoscopic delivery by far. And what was also interesting you can see here is that there was an equal number of recipients who are willing to have a physician recommend a donor as a family member. Little issues related to FMT will continue to evolve as our knowledge and our understanding of the microbiome evolves. And I'd like to thank you for your time and attention and just to quickly point out that this project and this research has really taken a village to do and I could not have done it with any one of these contributors to the project that we're doing now. So thank you all.