Fecal Transplants for C. difficile and More

Adapted from episode 69 of The Perfect Stool podcast and edited for readability.

Sabine Hazan, MD is Founder & CEO of the Malibu Specialty Center and Ventura Clinical Trials, where she conducts and oversees clinical trials for cutting-edge research on various medical issues. She’s board certified in Gastroenterology, Hepatology and Internal Medicine and is a top clinical investigator for multiple pharmaceutical companies. She also acts as the series editor of Practical Gastroenterology on the microbiome, a peer-reviewed journal that reaches 18,000 gastroenterologists, and is the lead author of the 2020 book “Let’s Talk Shit: Disease Digestion and Fecal Transplants”.

Lindsey:

So your book, Let’s Talk Shit: Disease, Digestion and Fecal Transplants, I noticed when I was looking at it that one of your co-authors is Thomas Brody who has been doing fecal transplants for years in Australia, right?

Dr. Sabine Hazan:

Yeah. Yeah. Master and pioneer of fecal transplants.

Lindsey:

Yeah. Well, so funny story about him: I’ve been obsessed with fecal transplants and this whole field for years, well before I was working in it. My previous career was in international education. And I was actually working at Georgetown University, in the Center for Australian, New Zealand and Pacific Studies, and we used to bring in visiting scholars and people to do talks and such so I realized there might be a connection there since he was from Australia, in which I could somehow reach out.

Dr. Sabine Hazan:

Oh, that’s funny.

Lindsey:

So I dug through old papers; I found his email and I wrote him and invited him to come and give a talk at Georgetown and he agreed to it in theory, but then I left that job, and I’m not sure, I don’t think that ever came to be.

Dr. Sabine Hazan:

Yeah, he’s a great guy. He’s definitely responsive to anybody calling him over the years; I cannot tell you how many gastroenterologist have said to me, “Oh, my God, Dr. Brody held my hand on my first fecal transplant; I was so scared; patient had C. diff and the colon looked awful and I was so scared to just put poop in there, and he just held in their hands.” And that’s what he does. He’s been a mentor to so many of us; he’s so open with his ideas and his innovations. And probably too much because people take advantage of him and use his ideas to make a business out of it. And I started collaborating with him and I said to him, we need to educate the people on what’s coming and we need to educate them on the microbiome. And it happened during the period of COVID in January 2020, where I thought the end of the world was coming is when I finished our book with Shelley Ellsworth, who basically helped us. And when we finished the book, I said, I’m not going to call it “Let’s talk microbiome”, I’m going to just call it what it is. So people are aware, because this is an emergency. And also in the book, there is a chapter that gives you an idea of how to survive COVID. And we actually mentioned in there, the microbe that we believe could be protective against COVID. And in fact, there’s a publication coming from my lab with those microbes, lost microbes of COVID-19, and that microbe is in there so…

Lindsey:

Then what is it?

Dr. Sabine Hazan:

So I forgot, which chapter it is, but at some point, the first third part of the book, I talk about the importance of bifidobacteria, and how people that have obesity tend to have low bifidobacteria. And if you think about it, that’s the same population that’s been hit with COVID, right? And so the first bacteria that popped up as being lost in patients with severe COVID was actually bifidobacteria.

Lindsey:

And that’s also something that decreases with age, right?

Dr. Sabine Hazan:

Yeah. And also something that decreases with age, is decreased in autoimmune processes. You know, it’s a very important microbe that is in our gut. In fact, it’s the microbe that sustains the whole billion dollar industry of probiotics, right? If you look at the back of all these probiotics, it says bifidobacteria. If you look at kefir, it says, “bifidobacteria”. How many products on the market say they have bifidobacteria bacteria? Right?

Lindsey:

Right, right.

Dr. Sabine Hazan:

And so that was the beginning. So to me, it was so important for people to read the book, because I said to myself, this is going to give them an idea about gut health and how to survive COVID. And at a time where we didn’t even have vaccinations or any treatment. And so that’s why I wanted it to be a catchy name. And also, I figured, I’m embarking in a world where I’m challenging the narrative a little bit. Dr. Borody and I, we’re scientists. So we are the rebels that are going to look the other way when everybody’s looking to the right, we will look to the left for the solution, right? Because if everybody looks to the right, then you never find anything, right? So imagine like you’re looking for gold and everybody’s looking in the same spot, well you’re never going to find anything.

Lindsey:

Yeah. So how did you get involved with FMT?

Dr. Sabine Hazan:

Oh, it was interesting. So my friend Neil Stallman, who was my mentor, and a couple of years older than me, and when I was in residency, he was in fellowship. He was in fellowship of GI at University of Miami and in Jacksonville, at Jackson Memorial Hospital and I looked up to him as a GI doctor, and I wanted to be like him when I grow up kind of thing. So I went into GI because I was always impressed by his way of being a physician. And his vision that nobody’s really right about anything, that we need to be looking constantly for solutions. And no science, no research is wrong. Everybody has an opinion. And so when I was a fellow at University of Florida, he took me around the posters. I was presenting my own poster; it was visceral hyperalgesia at the time, and he took me away from my poster and he said, “Look, look at this data, the future is in the microbiome”, but he didn’t say it like that. He said, “The future is in shit”. And I said, “Neil, if you bring me down that path, I’m going to hate you.” And basically, what happened is he went down that path, right, he started speaking, he would always invite me to all these meetings, ACG [American College of Gastroenterology] and he was always the main speaker. And I remember and I would do the clinical trial side that was cleaner, with pharmaceutical companies. I would basically do the new antibiotic for C. diff and the new pill, and when the pill wasn’t working, or the clinical trial wasn’t working, I would go to fecal transplant, and back then it was a lot.

I remember calling him for my first case that I was doing. And anyway because I didn’t call, I didn’t know Dr. Borody at the time, and I wasn’t going to call Australia. So I would call Neil and I would say, “Neil, how do I do this?” “Go figure it out.” I read all the literature, and then I figured it out. And I figured out my own little protocol, per se. And my first case was a physician. And I was shocked. And you know when you see a colon that’s a disaster inside with all sores and bleeding and mucus. And you go, “Oh, my God, I’m just going to put stools in there, and then it’s going to improve it?” And then sure enough, a week later, a month later, the patient is better, they stopped having diarrhea and something happened, right. And that was the first case for me. But I still didn’t like doing it because I had to put Noxema in my mask. Nobody likes to play with stools. So I was still the clinical trial girl. And if the client – and I would tell my patients, look, I’m going to put you in a clinical trial for C. diff . and if the trial doesn’t work, then I’m going to do fecal transplant on you. And I would use the funds from pharma to basically pay for the analysis of the stool donor and everything. In other words, they would pay me to conduct the trial. And I would use that money to look for perfect donors for these patients and their families, or using the spouse and making sure that that the spouse had clean stools, right.

And that’s how, when clinical trials became fecal material and the capsule, one could say, me and Neil joined forces because clinical trials became fecal transplant in a way. And so I joined the shit business, and then I said, well if we’re going into the pharma world, I better start looking at these microbes carefully, because what’s the complication of fecal material in the future and what are we doing long term to the patient’s short term, long term? Certainly I saw cases of personality changes with fecal transplant, BMI changing post fecal transplant, inflammatory changes post fecal transplant and then you start reading from other physicians, Colleen Kelly, Sahil Khanna and Paul Feuerstadtand you start reading all these other improvement or side effects, right? So you start educating yourself, and you have all these questions that are not answered. And when those questions were not answered, for me, I started wanting to understand the microbiome in a more personal way, because in my family, I had family members that I wanted to understand what was going on in their microbiome. And when I sent those tools to different labs, I wasn’t getting the same validated results. And not only that, but even in the bioinformatics pipelines, the bioinformatics pipelines were different. And so I asked the questions, well, how do we know what’s working and how do we know what we’re doing if the pipelines are not even validated, and the stool labs are not even validated? And so I set myself on a mission to understand the microbiome especially after I had a case of Alzheimer’s where the patient remembered his daughter’s date of birth after fecal transplant. And I did it for C. diff. I published that paper; it actually took probably about five years to get approved then published because they didn’t believe that the patient remembered his daughter’s date of birth. I actually had to send him the mini mental status of the patient with the square the triangles that are drawn perfectly fine. He went from a Mini Mental Status of 20-21 to 26, and then to 29, after six months. So to me, that was like one of those n of one that you go, wait, something’s happening in the microbiome with Alzheimer’s, we’ve got to pay attention.

Lindsey:

And he had C. diff . That was why he was…

Dr. Sabine Hazan:

He had C. diff. That’s how we were able to do it.

Lindsey:

Right.

Dr. Sabine Hazan:

And so I presented that case to all my colleagues, and they’re like, “Wow, that’s an amazing case. But that’s an n of one. We’ve not seen that.” And of course, you know, you saw the case of Colleen Kelly with alopecia areata and two patients. And then next thing, you know, the patients grew hair. And you have to ask yourself, well, what grows hair in the microbiome space? Right? Because Dr. Borody, he tried to do that on another patient and it didn’t work. So which makes you wonder, well, maybe donor matters. Maybe the microbes matter that we’re implanting. And so that was the importance for me to create Progenabiome with the interest and I realized, I was shaking the beehive a little bit, because every time you start something that’s new, and it’s a physician on the frontline of clinical research doing it,  it is shaking the beehive of what’s already there, right? Because if you find answers, there’s a whole industry that’s going to be gone. Right?

Lindsey:

Right, right.

Dr. Sabine Hazan:

Especially if let’s say we find answers for Crohn’s disease in the microbiome space, well, will the biologics disappear from these pharmaceutical companies? But I always believe, and that’s always the fear. And that’s why there’s always powers that try to destroy the innovations, right. But I’m a big believer that the same way that the post office works and email works, we didn’t decrease the work of the post office by bringing on emails; we just expedited the mail transfer back and forth between people in writing, right?

Lindsey:

Then started mailing everything packages and ordering everything.

Dr. Sabine Hazan:

Yeah, but the mailmen are still busy. And you know, I always joke, I say, we used to think like, well, we create internet, it’s going to remove the need for the post office. And it’s going to remove the need for books and library and papers, right? But the reality is, you’re busy in the real world, and you’re busy in the virtual world. You know, my desk is full of papers and my email has over 2900 emails that I need to deal with. So I’ve got this stack of papers on my desk that I need to deal with, and I’ve got these stack of emails I need to deal with. So I think in general, we’ve complicated our lives as human beings, period.

Lindsey:

Yeah, the pharmaceutical companies will find something else to work on if they don’t do the biologics.

Dr. Sabine Hazan:

I think we’re here to help pharmaceutical companies, right? Yeah, we’re here to help them improve their outcomes. You know, in medicine, it’s never a one pill solution. It’s never a one treatment solution. You know, you have patients that respond to Remicade, for example, but then they need nutritional supplements, they need a psychologist to deal with the trauma that started off the stress level that created potentially the dysbiosis in the gut, right? So it’s never a one pill solution. It’s never a one treatment. That’s why a lot of these patients, they need their psychologist, they need the nutritionist, they need their acupuncturist; they need all the ancillary support to help them function because it is a complex disease for a lot of people.

Lindsey:

Yeah. So let me stop you for a second and just ask, how successful is FMT as opposed to antibiotics for C Diff?

Dr. Sabine Hazan:

Very successful. So antibiotics . . . so what we’ve come to discover at Progenabiome is that if you look at the genetic sequencing of the microbes of an individual, you will notice that a majority have non-pathogenic  C. diff in their gut as their fingerprint, right? So if C. diff is in – in fact, it’s in my gut, it’s in all the GI doctors that have analyzed their stools. So one wonders, when did we get colonized with C. diff? We’re exposed to patients. Did I get C. diff somehow in the GI lab touching the handle, touching the door knobs, etc.? Is it part of our signature microbiome? If it’s been part of our signature, and I really believe that it’s been part of our signature for 1,000s of years, I think we all have C. diff in our gut as a baseline microbiome because if you look at C. diff, it’s 10 million years old at least right? They found it in one of the studies I remember seeing.

So if you’ve got C. diff in your gut, and you’re taking an antibiotic, what are you doing with antibiotics? You’re basically depleting the other microbes, right? So you’re allowing, in a way, C. diff to become pathogenic, to secrete its toxin, right? So because if you look at the microbiome of patients with toxigenic C. diff, you will notice that they have a lower diversity than everybody else, right? How did that diversity get killed? Well, it got killed with the antibiotics we gave them. So what am I doing when I give vancomycin? Well, I’m killing the diversity of the microbiome. So if you look at patients with vancomycin, their diversity is much less than a healthy individual and even lesser than a patient will C. diff because you just gave them the antibiotic. So what are you doing when you do fecal transplant, you’re not killing the diversity. You’re replenishing the diversity. So the message here, why is fecal transplant helpful with C. diff is because we’re replenishing the diversity of the human being; we are giving the human being a new garden in their guts; we are removing the weeds, which was the toxigenic C. diff that was taking over the gut because we killed everything around it. Imagine it’s like, basically, you’ve got this group of microbes and you just killed off all its families. Well, what is it going to do? It’s going to try to kill the host now right? You just killed off all its families. So now, what do you do when you’re replenishing? You’re replenishing new families. You’re calming that little microbe in a simplistic way, right? You’re appeasing the balance of the microbiome system and therefore the individual is healthy again.

Lindsey:

And do you use antibiotics prior to doing the fecal transplants?

Dr. Sabine Hazan:

Yes. So you always want to kill off as much as everything because you’re going to give a new microbiome.

Lindsey:

And how long do you use and which one?

Dr. Sabine Hazan:

So I use I usually do either vancomycin or fidaxomicin. Depending on coverage of the patient. Sometimes I’ll do flagyl; it’s not really great, mostly because most patients can’t tolerate it. But usually vancomycin or fidaxomicin.

Lindsey:

For how long?

Dr. Sabine Hazan:

For 10 days; 10 to 14 days. And then basically I do fecal transplant.

Lindsey:

And are you finding it hard to find donors who are qualified? Like will you take a donor that has C. diff?

Dr. Sabine Hazan:

No. No. Wait, wait. You mean non pathogenic C.diff?

Lindsey:

Yeah.

Dr. Sabine Hazan:

Oh, I’m going to find… yes, all donors have non pathogenic C. diff in their gut.

Lindsey:

Okay.

Dr. Sabine Hazan:

In the genetic sequencing. And this is a very, very important thing to mention. Toxigenic C. diff is the C. diff that secretes the toxin and therefore causes diarrhea. Non toxigenic C. diff is just a fingerprint of the microbe that’s really doing nothing in your gut. So even if you find it in the gut, it doesn’t mean that it’s doing anything,

Lindsey:

Is it a different strain, then what’s the name of the strain?

Dr. Sabine Hazan:

No, it’s still the same bacteria, but it’s not but it’s not potent, right?

Lindsey:

And how can you discern that in a…

Dr. Sabine Hazan:

Well, in a genetic sequencing world, you have to do a messenger RNA pipeline, to basically see if it’s reproducing. In a research world, in a clinical world, you have to do a PCR to see if you have toxigenic C. diff.

Lindsey:

Okay, so who does that test?

Dr. Sabine Hazan:

Oh, anybody does that test, all the GI doctors do that test. So if you have diarrhea, and you’re basically, you know, you’re going to go to your doctor and your doctor is going to do a C. diff by PCR to look for toxigenic C. diff.

Lindsey:

Okay. Got it.

Dr. Sabine Hazan:

And they’re looking at that point for a specific strain that stimulates… that, basically, they… if you’ve got the diarrhea symptoms, and you’ve got the C. diff positive by PCR, then by all that’s C. diff in the patient. What we look at is the genetic imprint of C. Diff; that doesn’t mean that that C. diff is doing anything. It’s most likely doing nothing, especially if the patient is asymptomatic. When you look at a patient and a donor, you have to do a whole bunch of a workup, right? So the first thing is obviously you do a GI panel. You know, you want to make sure you don’t have C. diff  and that donor toxigenic, toxin A and B so your test for C. diff toxin A,B, you’re going to look for Adenovirus, Campylobacter, E coli, Entamoeba histolytica, Salmonella, Shigella, Vibrio cholerae, Yersinia… you know there’s a lot of bugs that live in the gut. You want to make sure they’re not active in your donor because if you give those stools to a donor and there’s a lot more microbes, obviously, especially now with COVID, you have to make sure the donor doesn’t have COVID, right, in the stools, because if you’re giving it to an immunosuppressed patient who has C. diff to begin with, because he’s immunosuppressed, you could kill him. And that’s why we’ve seen the four cases post fecal transplant that died.

Lindsey:

Four? I didn’t realize there were four. From that same single donor?

Dr. Sabine Hazan:

No, no, no, no, there were two other cases that were brought up in probably in the last two years, I think. There’s been four cases altogether.

Lindsey: 

And were they from… I think the originals were from E. coli. Right?

Dr. Sabine Hazan:

Yes.

Lindsey:

And what were the others?

Dr. Sabine Hazan:

Yeah, I can’t remember what the other two were but I remember, it was like four cases.

Lindsey:

Okay.

Dr. Sabine Hazan:

I don’t think the other two they even knew what it was that we’re concerned about. You know, the patients were extremely immunosuppressed to begin with. So you don’t… in those patients, you have to try no matter what the risk, to look at the risk benefit ratio. But definitely, you know, that brought up the idea of looking for vancomycin-resistant E. coli. And I looked up, and then that’s basically why we are doing all these tests. And now with COVID. Look, we were looking for a donor recently in one of my patients that had C. diff, and I used her daughter as a donor. And low and behold, I found COVID in her stools, you know, so I can’t donate it to her elderly mother with COVID in the stools. So you know, so it is becoming challenging to find good donors. It is also becoming challenging, because with COVID, the microbiome changed with potentially vaccination, maybe the microbiome is changing; with the stress that people underwent, the post-traumatic stress from COVID and the quarantine and the wearing masks, the microbiome changes. Certainly wearing these masks all day long, full of infections, you know, is not really helping your microbiome because it’s… they’re infected and you’re just breathing in all these germs that are in the mask. So all that affects your microbiome, in my opinion, and so it is difficult to find good donors right now.

Lindsey:

Yeah. I know I’ve had a few people who’ve come to me wanting to use a relative for fecal transplants just doing it on their own. And, you know, I told them what tests to run and invariably, they show up with H. Pylori and with C. diff , and with all these other things, and I’m like, I can’t recommend that you use that person.

Dr. Sabine Hazan:

Well, that’s it. That’s the problem, right? I mean, it’s like that daughter that was healthy to begin with. But then I found COVID in her stools, right. So I’m not going to be giving a stool donor with 4000 copies of COVID, that I found in the stools to a little elderly woman, God knows that would shut down fecal transplants really fast. So we have to be careful. And it’s funny, because even the procedure, you know, we joke in the GI lab, because sometimes we’re sterile, we’re very clean, in the way we process putting the stools into the colon, right? And things happen and you’re like, “I can’t believe I’m that sterile, because I’m dealing with poop to begin with.” But we have to be sterile because unfortunately, the microbiome is fragile, it’s not meant to be put back right? Fecal material is meant to be out; that’s why God created us to have colons that evacuated our secretions, right, the bad stuff from our bodies get out. So that’s the whole process of putting it back into the earth, right? And then the earth processes and all these microbes, right? It was never meant to be put back.The fact that we’re finding some improvement with C. diff. To me, I think that C. diff was really the can that got opened to look at the microbiome and to look at the destruction that we’re doing, to say, “Hey, guys, you’re killing the microbiome.” And C. diff is popping up in these people and all these bugs, by the way that are super resistant, these virulent bugs. Bugs don’t just become Super Bugs, unless we do something to them to make them Super Bugs. And I think that’s the most important thing to reflect on, right? Especially with COVID. COVID just didn’t happen, right? The human microbiome has got to be pretty messed up for COVID to penetrate and create disease to begin with, or create people to die. So when you look at the people that are affected, the autoimmune people, the people with cancer, the people that are elderly, the people that are overweight, there is a picture there that tells you dysbiosis of the microbiome, penetration of COVID, penetration of COVID wouldn’t happen if that dysbiosis didn’t happen. I really believe that if you have a strong microbiome, and those are the people that are fascinating to me to study, and you’ve probably seen me on Twitter, saying, if you’ve not been vaccinated and you’ve now gotten COVID, please call me. I think these are the people that are super fascinating to study. Because in my opinion, they hold the mystery to why they survived COVID.

Lindsey:

Well, that would be my sister.

Dr. Sabine Hazan:

Yeah, so I’d love to test her stools, because, okay, those are the people that are… Yeah, no, I mean it’s fascinating, because I’ve been the guinea pig on this pandemic. And, you know, I test my stools on a regular basis, because I own the genetic lab. And I have to tell you, it’s fascinating to see my microbiome progress over time, during the pandemic. I mean, it’s been fascinating to watch so because I test if I take a medication, or if I get a vaccine, or if I get anything. I look at my microbiome. What is my microbiome doing while I took something?

Lindsey:

And yeah, what kind of differences do you just see over time?

Dr. Sabine Hazan:

Well, that’s going to be published, so I can’t really talk about it, but you are going to see it, because like I said, I am doing my timeline and I’ve been following myself and what I’ve done and what it’s done to my gut. But I think also, we’ve been following the guts of a lot of people and we’ve also looked at before the pandemic. We have probably over 1,000 stool samples. And we’re going to be looking at after the pandemic to kind of say, “Okay, well, what is different, right?” Because I think that’s fascinating data as well. And also correlating with those patients: whether they got vaccinated, whether they got treatment, some people are taking hydroxy, some people are taking ivermectin, some people are getting boosted and vaccinated. So it’s important to look at it to see what is all that doing to the microbiome, and then get a better idea of what the future is going to be and how to survive the next bugs.

Because you can imagine if you’ve gotten COVID, there’s obviously a dysbiosis in your gut that predisposed you to having COVID. So now the next virus that comes around has a potential of becoming super virulent in that person, so that’s why when you follow people who have gotten COVID the first time, then they get COVID the second time. If we don’t address the microbiome dysbiosis, it’s a domino effect constant until, you know, you wake up one morning with an autoimmune process or something. And you go, well, what happened? Well, the domino started way back when you had COVID. The first time that was your first sign, right? It’s like C. diff patients; you hear the story of a patient that gets C. diff and then down the road, they’re given antibiotics and then down the road they get an autoimmune process going on. You have to wonder that C. diff … was that the beginning? Was that the sign that said, “You know what, see, this was my first sign of dysbiosis. I should have paid attention.”

Lindsey:

But I mean, 80% of Americans at this point have had COVID. So I mean, how can you say that that’s all dysbiosis generated?

Dr. Sabine Hazan:

Well, is America a dysbiosis… dysbiotic country?

Lindsey:

Sure.

Dr. Sabine Hazan:

Is it

Lindsey:

What percentage of people in other countries? I don’t know those numbers? Are they getting a much lower infection rate?

Dr. Sabine Hazan:

I mean that’s it. Those are the things to look at; I mean, certainly America is high in processed food; they certainly take on a lot of microbes. They’re eating tomatoes in December; you look at Europe: they don’t mix microbes so much. You look at the American way of life: high, stressful, high go go go. Not as much as, if I look at the Spanish population, and again, Spain is becoming more America today. But if you look at the olden ways, where people used to sleep from two o’clock to three o’clock and rest, and it was like work, family and pleasure. Now we’ve become a society that’s just go go go; we’re on our cell phones constantly. We’re not doing any yoga, meditation, breathing; we’re not outdoors in nature; we’re not gardening. Certainly when you look at kids with ear infections, and you see kids in the classroom have more diseases and more infections than kids that play in the gardens. I mean, we’ve certainly seen those studies, where exposure to microbes from the earth definitely protects these kids, right? Is the American population, big on going outdoors, hiking, playing with the earth, gardening? Not really. So 80% of the population. If you look at the statistics of the American public, probably the 80% that got COVID is because they were not doing all these things. I can tell you that just with the people that I’ve treated, because I’m correlating that the people that do amazingly well are my farmers and my gardeners, you know. I have like husband and wife where the wife is gardening constantly, got COVID, mild symptoms and then the husband’s a physician and he’s high stress, he barely made it. So I think severity of symptoms also probably correlates to lifestyle and stress factors. Definitely, you know, in the stress from the news and listening to the television, and, you know, the drama, the conflicts and all that, what is all that doing to your microbiome, right?

Dr. Sabine Hazan:

Okay, well, let me stop you. Let’s dig into some other gut issues stuff. So with the testing you’ve done, have you noticed that there is a pattern of bacterial dysbiosis for certain diseases?

Dr. Sabine Hazan:

Yes. But nothing I can really discuss because it’s all preliminary data. So with me, you always hear that because remember, all data needs to be validated, verified and reproducible. There’s definitely a lot of interest. I wouldn’t be continuing this if I didn’t see something. But we are looking aggressively at diseases like Parkinson’s, Alzheimer’s, autism, ALS… That’s all interesting to me.

Lindsey:

Yeah. Okay. Now, on the Progenabiome website, I see blurb that says, “Want to learn more about gut refloralization, contact us below and we’ll follow up with you.” So I’m wondering, do you have options for FMT for people who don’t have C. diff?

Dr. Sabine Hazan:

We do not. We work with the agencies; we work with the FDA; we submit what’s called an IND [Investigational New Drug] to the FDA for emergency cases. So for example, I had a case of metastatic mesothelioma. So I submitted that case to the FDA to allow me to do fecal transplant; they approved it and we did it. So that was one case. We got allowed to do autism in one child; we are trying to get approved to do 30 kids. We’ve been working on it, mind you, for the last two and a half years. So it’s time consuming. It’s extremely expensive to put these protocols in to the FDA. We’re lucky because I’m a Research Center. And so therefore, I have a portal with the FDA that I use to submit all those INDs. However, it is expensive; it’s a lot of back and forth with paperwork. I think if you look at Alex Caruso, and there’s a lot of videos on the Malibu Microbiome Meeting. There’s a lot of videos because I do a lot of lectures with doctors that are doing fecal transplants. There’s going to be lectures from Dr. Sahil Khanna, Dr. Borody. It’s going to be on that website. So I encourage everybody to go to the Malibu Microbiome Meeting.

Lindsey:                                                                                   

I’ll link to that in the show notes.

Dr. Sabine Hazan:

Yeah, and this way, they can see the videos. Neil Stallman does a great lecture on Microbiome 101 for anybody that doesn’t know. Refloralization, I put it in there because it’s a vision of what I believe the future to be. I didn’t like the term fecal transplant. I know it’s been we retermed, Alex is calling it, Dr. Cruz is calling it microbiome transplant, which is a more appropriate term for it. I like refloralization because I believe we come from flora and we go back to flora. You know, the process of dying is our microbes in our gut get stronger and then they decompose our bodies back to the earth. So to me we go back to the earth; those microbes go back to the earth; the foods we eat come from the earth. So essentially, we’re feeding ourselves constantly with microbes from the earth, so from the earth to the earth. So I believe that in the future, it’s probably going to be more of a refloralization procedure, in the sense that finding what’s out of balance and replenishing it by what to create the balance. I think that’s the pharmacy of the future. That’s my vision. So that’s why I put the term refloralization; we are seeing certain microbes are improved with certain nutrients and certain vitamins and certain products. So that all plays a role in the refloralization process, in my opinion.

Lindsey:

So assuming most of the people who are listening to this podcast, they don’t have super healthy microbiomes. But assuming they can get back to a state of a healthy gut microbiome, what would you recommend for people staying that way?

Dr. Sabine Hazan:

Well, I think if you’re healthy, then keep doing what you’re doing, right? If you’re healthy, don’t do anything because whatever you’re doing, you’re doing great, especially if you have longevity in your family. Don’t mess that up, right. If you’re unhealthy and you have a family history of heart disease, etc. Well, that’s time to take charge of your health, right? And that means starting to educate yourself: seeking nutritionists, seeking naturopaths, seeking functional medicine doctors, seeking someone that will guide you in in a good way to proper nutrition and also help you with, I like to call it the fermentation of your gut right, so gut health really is what it’s all about. And gut health is not necessarily the same for every culture, right? Because you could see a Japanese person is eating Mexican food, you probably won’t tolerate it. And a Mexican person eating Mexican food will not tolerate Japanese food. You know, certainly I’ve been a gastroenterologist long enough to know that there’s certain foods that people don’t tolerate. You know, I think probably we’re born with a certain predisposition to eat foods from our culture and our races. And I think that’s your comfort food, you should stick to the comfort food. I think anytime people try to change what’s working is when they get themselves into problems.

Lindsey:

Okay, so I’ve had this theory for a while that issues with vaccinations are often related to antibiotic use and a dysbiotic microbiome. Do you have any insight into that?

Dr. Sabine Hazan:

No, I stay away from vaccines or discussing vaccination because I want to stay alive. Not that anything would happen but to me, but you know, vaccination is a complex product. It’s a complex issue. I don’t think anybody’s really looking at it. I think it needs to be looked at. I think anytime, look what we learned from antibiotics. Twenty-five years ago, antibiotics were given for everything, right. And what we learned from antibiotics is that actually, if you take too many antibiotics, eventually you’re going to have a little bug called C. diff. Because you’ve killed all your microbiome; you’ve killed your gut. I think that’s definitely established now. And people understand that:  if you take antibiotics, you have a risk of killing your gut. And that’s why the whole probiotic movement came on, because if you’re killing it with the antibiotics, you have to promote your gut with the probiotics, right? And thus, the movement of the yogurts and the drinks, and the probiotics, etc. I think there’s going to be a time that we’re going to figure out the same thing with chemo drugs; if you kill the tumor, you got to work on the gut, to support the killing of the tumor because you can’t just kill kill, kill, you’ve got to replenish. And again, the same thing we were doing with C. diff. We were trying to kill kill kill with antibiotics. But instead, we got people worse. What we needed to do was add more microbes. So I think there’s going to be a time that also people are going to start looking at vaccination and seeing maybe there’s something we’re doing with vaccination that needs to be supplemented with something else to balance the benefits of the vaccination with the disbalance that could be happening in the gut, for example. Okay, and I’m not saying that there is, but I’m just saying that I think we need to look at it, because it’s never a one pill solution. And it’s always a domino effect: action leads to a reaction with everything.

Lindsey:

Yeah, I’ll just add to that though, that I’m a supporter of vaccination, I have had my children vaccinated and myself and all that. But I’m just, I just look at..

Dr. Sabine Hazan:

I vaccinated my kids, I got vaccinated…

Lindsey:

Because there’s so many people now, because of the politicization of the COVID vaccine, now that are anti-vaxxers. And I feel like it’s an important point to not completely deny that there’s ever been any problem with any vaccination, because that’s what promotes conspiracy theories.

Dr. Sabine Hazan:

Yeah. And I think, yeah, and I’m not a big conspiracy theorist. And you know, it’s so funny because on Twitter; people think I’m an anti-vaxxer because I asked questions. Because listen: I’m a scientist. So if I’m going to have a person that comes to me and thinks they have a side effect to a vaccine, it’s my job to look, is that what’s going on there, right?

Lindsey:

Yeah.

Dr. Sabine Hazan:

So because in my world of clinical trials, when you have any investigative product and a patient has a side effect, any side effect, be it you know, pain in the mouth, be it headache, you have to document that; it’s called an adverse event. And if they end up in the hospital, or they’re having something that’s serious, like they’re paraplegic, you know, I look at the case of Mattie de Gabbé, which I got involved in looking at her; you have to pay attention to that, because that’s a serious adverse event. And serious adverse events, we cannot ignore them because they tell us something else in the future. So I think it’s our job to pay attention to everything. I think, also, you have to pay attention to the people that it doesn’t work for, right. So the people that got vaccinated and still got COVID:  you’ve got to ask the questions.

Lindsey:

Yeah.

Dr. Sabine Hazan:

So just because I’m asking the questions, doesn’t mean I’m an anti-vaxxer. It just means that I’m a good scientist for asking the question.

Lindsey:

Yeah, yeah, no, I and my children were vaccinated and boosted and still got COVID, but it was Omicron. So that was sort of expected since that was less sensitive to the vaccines.

Dr. Sabine Hazan:

Yes, yes.

Lindsey:

Okay. So you mentioned that the people who were most susceptible to COVID had low levels of Bifido and I’m just wondering because actually I did Thorne’s sequencing of the microbiome, and they said I was lacking Bifido. And to take rice bran… well, they said… I can’t remember the name of the actual fiber, but it was essentially rice bran.

Dr. Sabine Hazan:

Right.

Lindsey:

So I’m taking that, but other than taking probiotics with Bifido and that, what else can boost Bifido?

Dr. Sabine Hazan:

So I have to warn on that, because I never put myself in the position to kind of say, yes, we found this. It’s research, right? So it’s my hypothesis. It’s a finding. It’s a small study and needs to be done as a bigger, larger scale, obviously. So I don’t want people like leaving this and saying, Oh, my God, I’ve got to check my Bifido to see if I’m alright. Right? Because until other doctors validate, verify, and we produce the data, it’s still research on one site.

Lindsey:

Right, right.

Dr. Sabine Hazan:

So I think if it doesn’t hurt, yeah, take whatever was suggested. But if it becomes like a heavier treatment or something that is risky, I probably would stay away from that, not necessarily trust those labs. Remember, these labs are not validated and not clinical, right? They’re just a consumer product that’s out there. But the majority of these labs are not even CAP or CLEA certified. So it’s very important when you do your stool testing. And remember, we’re in the research; we’re writing the data. And we’re not a commercial stool sample yet, because there’s so much to learn. So you got to be aware of stool companies that are selling you these tests. And then telling you, you have low Bifidobacteria, because maybe they’re trying to sell you a probiotic for one. I know, we have validated a couple of those lots, because my patients come to me and say, “Look, I just took this probiotic from this company. And you know, my Bifido was low, and then we compared it and we couldn’t find that their Bifidos were low. So you got to be careful of anything out there. It’s all research. And everybody needs to understand it’s all research.

Lindsey:

Well, it wasn’t the first low Bifido reading I’d had. I certainly had other probably 16s sequencing that showed low Bifido as well.

Dr. Sabine Hazan:

Yeah. So that’s good. So you validated yourself.

Lindsey:

Right, right. Over time. So are there any other diseases where you’ve noticed changes when incidentally you were doing the transplant for C. diff?

Dr. Sabine Hazan:

We are working on autism right now. We’re going to try to bring on a protocol for Parkinson’s and Alzheimer’s. I’m working with Dr. Sheldon Jordan at UCLA, who is the top interventional neurologist, in my opinion. We’re also working with anxiety with Dr. Sasha Bystritsky. So that’s going to be an interesting study. We feel that we see something in anxious patients’ microbiome. So we’re evaluating that closely.

Lindsey:

And are you just looking at what is going on in the microbiome? Or are you making interventions?

Dr. Sabine Hazan:

No, we’re looking and we’re making interventions. So we’re basically… remember, I’m a research center. So we have access to animal labs. So right now, we’re looking at an animal marker for Parkinson’s. So we’ll see. I mean, the future is exciting. We’re seeing some things. And we’re going after it full blast. And we’ve been lucky so far, so we’re still above the ground as far as finances, but people can support the Microbiome Research Foundation, because that’s how we make all these trials possible, and this research possible. The paper for COVID, the lost microbes of COVID, or finding COVID in the stools was paid by the Microbiome Research Foundation. So please put that on the links so that people can support that. So that’s how we advance science through research; through donations.

We’ve been fortunate; a lot of patients I’ve helped over the years that you know, I’m in Malibu, so I have an affluent population; and they’ve been coming forward and been very generous in in supporting us. So and also the patients, you know, the patients support us, so it’s been amazing to help people. And to see and to kind of go into the research with them and see what we see and saying, “Look, it’s research. This is what I see. I could be wrong, but I could be right. And this is the beginning.” You know, and having frank, honest discussion with the patients and giving them a consent because really all our research is consented. Anytime anybody gets tested with us with the microbiome, it’s all research so they have to sign a consent before they get tested or if we test their kids with autism, etc. They have to sign a consent. We are supervised by a regulatory board that overlooks all our IRB that overlooks all our research we’re doing. You know I thought Howard Young at the NIH said, “This is the way to do it.” And I’m doing it. So I wrote 52 clinical trials on the microbiome and disease. I’m looking at every disease and every skin condition.

I’m very fortunate. My sister is the top dermatologist in New York City. I have another sister who brought HARVONI and Ivermectin in the market. So we have a huge database of patients through clinical trials over the years. So we’ve been able to utilize these databases and put patients into clinical trials, to at least get a beginning of a view of what does Parkinson look like in the microbiome; what does Alzheimer’s? So we have an idea and we’re continuing slowly, slowly, and eventually, as we publish, I encourage everybody to go on the Progenabiome website, because it has publications. We’ve published about 35 papers, I think, in the last three years. So you know, it’s moving. I have 52 more papers to go. We have a lot of scientists helping me and we encourage collaboration from everyone. Anybody that wants to be involved, please, you know, we’re all inclusive. Like I said, I’m a Research Center. I’m a research lab right now, research genetic sequencing lab. I’m not a commercial. But anybody that wants to get involved and has something that they want to crack the code of, you know, can help us and together hopefully we’ll join forces. I am fortunate I have a lot of doctors, a doctor from Turkey that I’m working with. Right now, we’re looking at Crohn’s and Ulcerative Colitis together. Dr. Borody has been an inspiration and definitely a huge mentor and a huge brain and genius.

Lindsey:

Yeah, speaking of him, I would love to get him on the podcast. Any chance you would introduce me?

Dr. Sabine Hazan:

Oh, yeah, absolutely. I could do an email. He’s extremely busy right now because he’s trying… we started off that controversial triple therapy for COVID with Ivermectin, doxycycline, zinc. So  he’s busy fighting the wolves, because he wants to see that going. You know, he was behind the therapy for H. Pylori. So patents is his world and combination therapy is his world. And he’s a genius. I’m so fortunate to be working with the man. And I’ve done my part, which was like doing the clinical trial with the FDA. So now it’s on to him to take it to the next level. That was not an easy trial to do, and certainly a lot of politics, controversy behind it so…

Lindsey:

Okay, well, I appreciate that. Even if he doesn’t have time, maybe he will eventually.

Dr. Sabine Hazan:

Yes, yes. Yes. For sure. I think yeah; as he kind of like figures out this whole triple therapy. What he wants to do with it? I think that probably would be the best time.

Lindsey:

Okay well, thank you so much for coming on and sharing about what you’re doing at Progenabiome and I look forward to talking to you in the future sometime.

Dr. Sabine Hazan:

Yes, absolutely. Thank you so much.

If you’re struggling with your gut health, you’re welcome to set up a free, 30-minute breakthrough session with me (Lindsey). We’ll talk about what you’ve been going through and I’ll tell you about my gut health coaching 5-appointment program in which I recommend lab tests, educate you on what the results mean and the protocols used by doctors to fix the problems revealed. Or if you’re ready to jump in right away or can just afford one appointment at a time, you can set up an 1-hour consultation with me.

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