FMT FAQs: Tom Lendvay Talks Poop, Process, and Potential

Tom Lendvay, Chief Medical Officer at Tend, is a surgeon, entrepreneur, and Professor in the Department of Urology at the University of Washington.

As one of the co-founders of Tend and a vocal advocate for FMT (Fecal Microbiota Transplant), he’s quick to respond to frequently asked questions about this life-changing treatment for Clostridium difficile—and what it could mean for other serious conditions.

We’re happy to share an excerpt of a recent interview below.

**We see all this evidence and discussion about FMT and its efficacy for treating Clostridium difficile (C. diff). If it’s proven so effective, why isn’t it happening more?**

Right now, there are a lot of barriers, starting with the way clinicians have to process somebody's healthy microbiome to be able to give it to an ill patient with a Clostridium difficile infection. The whole process is laborious. It's messy. And it's not standardized.

The treatment, in its simplest description, involves taking a poop sample from a healthy donor, putting it into a blender, mixing it with saline, filtering it through cheesecloth or a number of sieves, and then putting it back into an enema bottle or a syringe so that it can be placed through a colonoscopy and injected. We've heard from people who do the processing that it takes six to eight hours to process a single healthy donor’s sample. And that requires a lot of labor, so most have to hire somebody to do a lot of it.

The patients are also experiencing a very invasive procedure to receive treatment. They have to go under general anesthesia for a colonoscopy to administer it. That's a big deal. And everybody knows what it's like to have to do a bowel prep or cleanse their system before a colonoscopy. It’s not just an in-and-out thing.

Other routes aren’t much better. If you've ever had a nasogastric tube, another way of administering it, that's a really unpleasant experience having a tube put down your throat and into your stomach.

And if you're getting an enema solution, that's also not pleasant. Once administered, you have to sit on the floor and roll around so that the solution that's in your colon mixes around.

All of these are really unpleasant.

Another big barrier is that you have to screen the donors providing the stool sample for transplant to a patient. You have to make sure that what they are donating is, in fact, healthy and safe—which includes making sure the sample is not contaminated with HIV or hepatitis viruses. Everybody who provides a sample has to be carefully screened to make sure that they don't have these pathogens or that they don't have bacteria that can harbor anti-microbial resistance.

All of these barriers mean that there is a lot of room for improvement, and that’s what makes the work at Tend so exciting. We're looking to improve the experience for the person processing the sample. We’re looking to improve the experience for the patient who has to have the sample administered. And we’re also working to make it easier for providers to be able to screen potential donors for their patients.

You mentioned there’s no standardized method for preparing these various methods for FMT treatment. What’s bad about that?

It's really hard to compare apples to apples. Say I'm one site, taking care of patients who have Clostridium difficile, and I want to see how my patients are doing relative to others receiving FMT. One site does it with colonoscopy. One site does it with enemas. One site uses a small amount of stool material. Another site uses three times as much material. With those kinds of variations, you really can't tell what seemed to work.

If one method worked for patients in one lab and it for the other patients in another lab, was there some common ground? Is there something that is similar between the samples or how the processing was done?

So the field itself only advances as fast as we can make things consistent, reportable, and collected. Right now, we’re in this place where basically every lab is functioning in its own way. It becomes really hard to spot broader solution opportunities for a larger number of people because of the diversity in processing approaches.

So if we remove these barriers, what gets better? Is the potential to expand the universe of clinicians offering FMT, or will this be more about making it a heck of a lot easier for clinicians (and their patients) who offer it already?

We're doing both, but I really want to focus on expanding the pie. Currently, 55% of FMT’s, or as we like to call them, gut microbiome transplants in the United States are performed through colonoscopy. Most recurrent C. diff infections are diagnosed and cared for by general practitioners or infectious disease doctors. Colonoscopies add additional layers of burden to the patient. They have to be referred to a proceduralist—in this case, a gastroenterologist—to administer the treatment. They have to undergo an invasive procedure under general anesthesia. And they have to manage all the details.

What we’re striving for is actually enabling existing and new providers of FMT with a way to directly provide gut microbiome transplant care to their patients—without the need for invasive surgery or involving another specialist. Our device allows a sample to be processed into capsules that can be frozen and then taken orally by patients. That means empowering non-procedural providers—infectious disease doctors, general practitioners, naturopaths, functional medicine doctors—to provide this potentially lifesaving intervention or therapy without the burden, expense, and complications of surgery.

At the same time, it’s important to note we’re not undercutting GI docs. When we’ve talked to gastroenterologists, they’ve told us they’d prefer a less invasive method for gut microbiome transplant to their patients if they had that option. Colonoscopy is invasive generally and FMT patients can sometimes be pretty frail, so the risks can be higher. If instead, patients could just take some capsules to do the same work as an invasive colonoscopy, that’s something we think gastroenterologists would prefer.

With these capsules, a gut microbiome transplant specialist within a gastroenterology practice doesn’t have to be the only one who can administer this treatment. You can now directly take care of any patient who has recurrent C. diff.

So whether we’re talking about opening things up so that more types of clinicians can offer FMTs, or expanding the number of GI docs who can offer it, we see our solution as basically democratizing the ability to provide this care. And that’s important because the more provider practices there are that can process, deliver, and use FMT, the more patients can be saved from a disease that kills over 500,000 people in the US each year.

What about the microbiome tests that are part of this wave of home testing products we’re seeing for consumers—the ones where I can order a test online, send in a sample, and get a picture of my microbiome. How do these fit into the patient/clinician picture for thinking about the microbiome as a tool for health?

Yes, there are a number of microbiome testing products out on the market—and the majority of them are geared towards pointing the consumer towards purchasing some type of supplements, usually probiotics or prebiotics. Very few of them deliver really meaningful feedback for the providers, in a digestible way that can inform the health dialogues between clinician and patient.

This seems to be a recurring theme. When we talk to clinicians, they mention their patients will come into the office and say, “Hey, I did this microbiome testing, and here's the report. What do I do with it? What does it mean?” And the clinicians are at a loss because they don’t have much visibility into the testing parameters of whatever off-the-shelf tests their patient brought in. In some cases, the clinicians themselves may not be heavily trained in microbiome science—and it’s fair to say few are. The field itself is evolving so rapidly that it's really hard to actually stay on top of it, unless that’s all you do.

Unfortunately, the consumer tests so far don’t do much to inform the clinician-patient relationship—and it’s also hard to point to what they actually provide health-optimizing consumers either. The microbiome is just so complex. There isn't “A” healthy microbiome that is or should be the same for everyone. That's a misnomer. There are plenty of people whose microbiome composition suits them just fine. One person could have a hugely different microbiome from another, while both could have very normal, healthy functioning guts overall.

And therein lies the problem—and the opportunity. There’s not really a good reference to cite for people. There is certainly literature on knowing some signatures of bacteria groups or bacteria family members that tend to create problems for people. But a lot of the testing that exists for consumers doesn't actually go into that level of detail. And even if it did, a clear linkage between a certain microbiome composition and what kind of nutritional or supplement steps could make it “healthier” just isn’t there yet. It’s really hard to say that we can take a test and reliably point you to X, Y, or Z supplements that will help.

While the consumer tests are likely more of a loss leader to funnel toward more revenue-generating products, their popularity is a sign that the public is ready and willing to learn more about the gut microbiome. And that’s a good sign. It’s also a sign that we have more work to do to create a deeper, clearer understanding from a clinical perspective.

Consumer microbiome testing sounds a lot like what’s happening in blood testing, DNA testing, and food sensitivity testing these days. Is that because the bridge to clinical value just isn’t buildable today?

We don’t think so. Rather than trying to sell any type of additional products, we're trying to bring enlightenment to patients and better dialogue with their clinicians, particularly when it comes to thinking about the relationship between their microbiome, health, and available treatments.

This is really where we see a big gap we can help fill. By offering microbiome testing and analysis tied to multiple points of treatment, we can all get a better understanding of outcomes over time. More specifically, in the case of FMT—a treatment we know that works—we can get better answers across the treatment journey, down to the patient level.

For example, we can start using testing and data solutions to help understand who's the best donor for specific recipients. Let’s say you have a C. diff infection, and your provider says, “You know, none of these antibiotics have helped you. You keep getting recurrent episodes. You're miserable. It's time for you to do a microbiome transplant.”

At that point, we’re going to be helping your clinician capture your microbiome signature and compare it with the microbiome signature of your healthy donor. After you get your transplant, we’ll continue to monitor your progress with sample testing so we can marry the information about how you did after your treatment. Did you respond or not? Did your symptoms go away? To what degree? What lifestyle and phenotypic factors—from both you and your donor—may have impacted your outcome?

And the more people who go through this process, the better and bigger the picture becomes.

Over time, we believe we can help clinicians figure out how best to match donors and patients and which patients may not respond at all. Maybe we can help point the patient to a different therapy because they have a minimal chance of responding to a microbiome transplant. Or maybe we can identify patients earlier upstream and say, you know what, before we send you on three or four courses of expensive antibiotics that have a minimal chance of working, maybe you should just go to FMT right away. For many patients, it’s often the most affordable, effective, and fastest road to recovery. It no longer makes sense for it to be the last course of treatment.

To answer your question, yes, the bridge is buildable. Especially because our testing and data solution is deeply rooted in making sense of the science. It’s targeted towards clinicians who want to have counseling discussions with their patients, and it’s designed to make it easier to interpret, understand, and talk about what's going on in a patient’s microbiome—how it relates to treatment and healing journey.

For more information on how Tend is Making it easier to access, understand, and use the gut microbiome, contact the team here.

FMT, From the Tend teamIna CorverMarch 9, 2022