Innovations to Improve Food Allergy Prevention and Care with Meenal Lele

Meenal Lele is the founder and CEO of Hanimune Therapeutics, which she founded with the aim of developing food allergy preventative products. The company's goal is to create solutions for parents preventing food allergies and doctors seeking better options to support tolerance. The company's commercial branch Lil' Mixins provides products making early allergen introduction to infants in a safe and controlled manner. 

In our conversation we explore her groundbreaking innovations in creating "non-allergenic" peanuts and other top allergens and the vital connection between the gut microbiome, allergy development, and mental health. We also explore how anxiety plays a role in allergy management and treatment, and her perspective on how reducing anxiety around this might benefit patients.

Lele's book The Baby and the Biome is a great resource for anyone interested in prevention and microbiome health.
The Baby and the Biome a book by Meenal Lele and Cezmi Akdis - Bookshop.org US

Resource Hub – Lil Mixins
Hanimune Therapeutics

Preventing Food Allergies in Infants Guide by foodallergyprevention.org and FARE: Clinician-Guide_FAPrev_2.24.pdf

Special thanks to Kyle Dine for permission to use his song The Doghouse for the podcast theme!
www.kyledine.com

Find Dr. Whitehouse:
-thefoodallergypsychologist.com
-Instagram: @thefoodallergypsychologist
-Facebook: Dr. Amanda Whitehouse, Food Allergy Anxiety Psychologist
-welcome@dramandawhitehouse.com

Transcript

Meenal Lele: 0:00

one of the weird things about becoming a parent, I think, or at least for me, was that in a way that you never did before, you don't just care about your own kid. You become very, empathetic with all other parents and all other children. When this happened to my son, my brain was really going immediately to, but what about the kids who won't have a parent who is studying this stuff and who won't know how to navigate the system? How are we going to do something about that?

Speaker: 0:27

Welcome to the Don't Feed the Fear podcast, where we dive into the complex world of food allergy anxiety. I'm your host, Dr. Amanda Whitehouse, food allergy anxiety psychologist and food allergy mom. Whether you're dealing with allergies yourself or supporting someone who is, join us for an empathetic and informative journey toward food allergy calm and confidence..

0:49

Welcome back to Don't Feed the Fear. I had the most interesting day in Albany this spring doing some advocacy work for food allergies. One of the reasons that that day was so interesting was because I happened to meet Meenal Lele. She's the founder of Lil Mixins and Hanimune Therapeutics, and someone who is truly shifting the landscape of food allergy prevention and treatment. I was just so impressed by who she is as a person, her motivation for helping others and her innovation in the world of food allergy. If you're a fan you know that we don't do short and sweet conversations. I always have so many questions from my guests and I wanna do the deep dive. So Meenal joins me for that today, talking about her professional experiences and how her own child's food allergy led her to develop an accessible evidence-based tool for early allergen introduction and also groundbreaking work on re-engineering allergens like peanut to reduce risk and improve immunotherapy safety. Meenal also wrote a book called The Baby and the Biome about the role of the gut microbiome in food allergy development and overall wellness and in mental health, which is something that she and I enjoy talking about very much, and I think that you'll enjoy that conversation too.

Amanda Whitehouse, PhD: 1:58

Meenal, thank you so much for joining me here and don't feed the Fear., I got to meet you in Albany a and see your advocacy work at the Capitol Building, and I'm so excited that you were able to make more time to talk today. Yeah, absolutely. I'm excited to be here. Good. Well, I know there's so much we wanna talk about. We were sneaking in all these little excited conversations in between our meetings, jumping from office to office. So a good thing, we have a platform for it now, but let's start, in terms of telling people, who you are and how you got into what you're doing now?

Meenal Lele: 2:27

Well, yeah, let me, I guess by way of introduction, I suppose many people think of themselves first and foremost as like a food allergy parent, right? That is really what drives this lived experience as a, as a caregiver, is what drives a lot of the work that we do. Where this all comes from though, is I have a long career in, the medical industry, and I think that's a very different perspective that I bring to things. Coming at it, not just as a parent. But as someone who has built solutions and companies in different aspects of medicine, so I have a dangerous amount of information about how our medical system actually works. And that is, you know, for the better and for the worse. But when my son first got sick, you know, a lot of people really think of things at that surface level, which is obvious. Like, oh, someone is sick, they need treatment, they need care. And my brain immediately went to. All of the gaps in our system that were going to make that really difficult. Not just for him or not for us per se, but for everybody else. And, one of the weird things about becoming a parent, I think, or at least for me, was that you in a way that you never did before, you don't just care about your own kid. You become very, empathetic with all other parents and all other children. And so when. When this happened to my son, my brain was really going immediately to, but what about the kids that you know who won't have a parent who is studying this stuff and who won't know how to navigate the system? How are we going to do something about that?

Amanda Whitehouse, PhD: 4:05

Yeah, that's how I feel about what you're saying. I want to get everything and all the information to all the kids out there, you know, and so many of them, like you said, will have barriers. To accessing the information and the treatments and the protection and testing and all of it.

Meenal Lele: 4:19

Yeah, absolutely. And I think because as a parent you make so many mistakes, right? Even when you're doing your absolute best, you make so many mistakes and you just realize how random life is and how by just by sheer coincidence at certain things work and certain things don't, you know? And so that even when we wanna be proud of ourselves for doing the right thing, we realized a lot of that was just chance.

Amanda Whitehouse, PhD: 4:42

Right and luck. One of the things that comes to mind with that is what you and I were talking about, in Albany when we were doing the advocacy work how, some of it's chance, some of it was knowledge and timing with both of us, our oldest having food allergies and then getting that LEAP study information and our, our younger kids not developing the allergies because we then had learned about early introduction but I look back on the initial thing as like my mistakes and what I didn't know, and it's hard to process all of that, I think. Absolutely. For someone who is not in the medical industry at all, that's a very broad term, can you say a little bit more about what kind of work you were doing prior

Meenal Lele: 5:17

yeah, sure. Um, through a random series of events. Um, way back in 2008, I had been on the founding team, or I was on the founding team of an orthopedic company and we grew that business, really quite big, and eventually sold it. And then I left there to be the first employee of a vascular medicine company. So two actually very different areas of medicine. Orthopedics is kind of more of a, it's in the hospital, but there's a lot of private practice. The vascular medicine is all hospital based. Um, and then that company eventually sold as well. And the both companies when I joined were. Still in, in infancy. I mean, the, the first one was literally a napkin drawing at an Italian restaurant. And the, this, you know, the second one, they had prototypes and other things, but it was pre-human use. And so, you know, you put. Like so many things in life, the end product is very different than, you know, it hides all the stages. Like you think even making a cake, right? You get this beautiful cake that's presented and nobody sees behind the kitchen at like the knives that were thrown at each other, and the cake flour, that's everywhere and you know, all the messes that happen. Um, so you, you, we tend to only see the output product, not all of the. What had to happen to make that possible. And so really, um, I got a really a, a front seat sort of perspective, not only on what does it take to bring products to market, but how in, in the, in everything medical, the doctors are largely your customer. And that's a very, very different customer, um, with very, very different needs than when we think of a quote, consumer product. Doctors don't generally get to make their own decisions, in many ways, it's a very constricted market in that there's all these constraints about payment, right? So even when a doctor might want to buy or. Prescribe, let's say in this case, a drug. They're very constrained by what insurance you have. So you think it's the doctor making the choice, but it's not, it's some payer or it's the hospital system or, and in each case there's all these bits that, that are coming together and you almost have to, to be successful, you have to really see that minefield ahead of time and plan

Amanda Whitehouse, PhD: 7:38

your strategy through it. I assume there are others too, the barriers that you were talking about that you could see that would lie ahead before you even got started

Meenal Lele: 7:47

Yeah, absolutely. Um, I mean the, the biggest barrier as I actually was talking to another founder just recently, they wanted to start another company that their target market is infants. I brought up that in the United States, 60% of infants are on Medicaid and chip, and this founder didn't know that. But that is such a fundamental piece of our system that again, when we watch TV or we think about consumer products, we're really thinking about a very small sliver of the population that has the cash and capital to do things and the education to do things. All sorts of different things again, that, uh, work together., It depends on what kind of problem you're trying to solve, right? If you just wanna get a product to market that will be profitable, you might be able to do that. Just working with 5% of the population, right? There are, I don't, I don't know, hair salons and things that work if you're, even, if only you know, a tiny group of people is using them, and that's fine. Um, in medicine, specifically preventative medicine. Preventative medicine, that is always a universal approach. So if you're saying from the outset that you want to do something that by necessity has to get to a hundred percent of people, or realistically, 95%, let's say. Well. How will you do that? Right now you're talking about multiple disparate groups of people with different needs and different constraints, and so you have to be thinking ahead of time about what, and often you're only allowed to come up with one solution that has to work for all of them. So what does that look like and why? You know, so we, um, so that was that. I think that's just a very different approach to this market than, um, preventative medicine is just a very different beast than everything else.

Amanda Whitehouse, PhD: 9:41

Right. Right. And so the company is called Hanimune. And you began with one branch, which is the direct to consumer marketing of, of in early introductions. Lil'Mixins. Allergens, right. Sense? Yeah. So, so tell us why you decided to start there, or was that the original plan

Meenal Lele: 9:56

The original plan was always to do both sides, but you gotta start somewhere. You gotta do one thing right before you can go get to do your second thing. And um, I started with Lil' Mixins'cause it was kind of the easier one to start with. It's a easier area in, in. Some ways to get the ball rolling. It's definitely the harder one to succeed, but it's the easier one to get started. So we started there.

Amanda Whitehouse, PhD: 10:21

FDA approval and the, the whole Exactly.

Meenal Lele: 10:24

Prevention fundamentally falls into a category called dietary supplements for foods, or it can, uh, again, I think easy way to think about it is, um, prenatal vitamins, which are vitamins. So they're dietary supplements. They're not drugs. They don't have FDA approvals. And, uh, so similarly you can do something in this space'cause that's really the most cost effective way to solve the problem. Um, so you can start there and, but our goal was really to build and use that to eventually get to the treatment side because not every child. You know, we, we now in allergy, or they now in allergy, talk about primary prevention, which is the prevention we do with infants in this universal. Then there's something we call like secondary prevention, which is there's these kids that develop allergy and infancy and there's a, a thought process that a specific kind of intervention could kind of like, while their immune system is still sort of deciding what to do, flip them back. To tolerance,. And then there's this idea of, you know, tertiary prevention or, or really treatment at that point. Right. Um, and so you kind of work your way down, uh, work your way down from easiest to hardest technically.

Amanda Whitehouse, PhD: 11:37

If people aren't familiar with Lil' Mixins. tell them exactly what the product is.

Meenal Lele: 11:42

Lil' Mixins is straightforward. The top seven proteins really, we don't do wheat and milk because those are already in the infant diet. But the other, seven protein seven big proteins that babies tend to develop allergies to. They're in cost-effective, infant safe forms. Just a concentrated protein. And the idea is, you make it super simple for a parent to make sure that a baby's eating two grams of that protein in a sitting. So there's no thinking involved. There's just, there's very little thinking involved. And if you can do that in a way that's, you know, again, cost effective and easy to reproduce, we can get, more babies to do it or parents to do it.

Amanda Whitehouse, PhD: 12:21

So they're just little packets, little dried pouches that you literally mix in, right? That's exactly right.

Meenal Lele: 12:25

And, and for more, even more cost effective forms, we sell them. We also do these jar form factors, so you can get almost six months worth of servings in a single purchase in a single jar, and then it becomes more cost effective.

Amanda Whitehouse, PhD: 12:37

Okay, so that is to help parents who want to take advantage, who are educated. Hopefully it's becoming more and more people that early introductions is the, best way to prevent allergens and make it really easy and take the thinking out of it.

Speaker 3: 12:50

Mm-hmm.

Meenal Lele: 12:51

That's absolutely right. And the jar form factor, again with really from the beginning, because we said if insurance is ever to pay for something, they will not pay for multiple things. They will only pay for one thing. So then all of the stuff that a parent needs has to fit into one thing. And that was actually, a key design constraint. Which, some parents appreciate, but if you're buying something over the counter, most parents really want the convenience of the packets. But insurance will never cover that. So, you know, we separate, we have to separate them because you don't want it to be unusable with a child that has one, right? So you have multiple jars. So the, the way we broke it up is basically like peanut eggs and then the tree nuts.

Amanda Whitehouse, PhD: 13:34

And those, those products are pretty widely available and you can order them online now. Right. Um, but you've got other things in the works. So take us into that part that, that branch of the business and where you're at with that.

Meenal Lele: 13:46

So food allergy treatment or all allergy really is, the way we treat it fundamentally is we desensitize someone to it. There are many drugs that are in development right now. Most drugs, they work by changing your immune system or suppressing a piece of your immune system. And so like with all, there is one maybe a lot of people are familiar with and there's many in development. Allergy immunotherapy or the process of desensitization. We are trying to get your immune system to stop producing antibodies. And the way our immune systems are designed is that once we have made this decision to create a kind of antibody against a virus, a bacteria, a parasite, or you know, anything, we do it forever. And so this desensitization process is trying to get your body to rethink that decision, and we know it works. So food allergies have been desensitized for over a hundred years, and many people with allergies also have environmental allergies. And so you know the process of allergy shots is you start with a little and you slowly increase and you get your body to stop in some sense, that's a little hand weighty, but you get your body to stop producing the antibodies. And the question, the, the issue with food allergy is that our immune systems, to a large extent, are actually in our GI tract. And so when we ingest antigens the foods, we get these very violent responses And food allergy can be really dangerous because of the amount or the, I guess the number of immune cells that are involved in various things that. You know, we don't need to get into, and again, I, forgive me, I'm really hand waving over a lot of things. So whenever you have doctors listening, they're gonna be like, well, that's not technically correct, but we're hand waving here. So in any case, what we have been trying to do is figure out how to solve the problem of the safety side of it. And so we're not fundamentally trying to do anything different. We're not trying to say that. It creates a magical new way of desensitization, desensitization. Fundamentally, you start with a little, you get add more and more until your body changes. Its your immune system changes its mind. What we're trying to figure out is how can we get the body to make that decision with as few side effects as possible. One way people now do that is they suppress their immune system during desensitization with Xolair. And that in clinical trials has shown a bunch of, uh, promise. Our thought process, um, from an engineering perspective was to say, well, what if we played around with the antigen itself? Is there a way that we could get the, we could change the antigen so the body would accept it in order to use it? For this purpose of creating tolerance but not react to it. And so, um, we've started this line of proteins called Top nine Proteins. Um, they're all still really supplements and so they are. The proteins, the, you know, the, the food proteins. And in some cases they, um, they're really how, again, it's all about how it's being presented to the immune system. So we're not saying that they're not a peanut anymore, right. It still is fundamentally a peanut. But we're messing around a little bit with the, the delivery mechanisms and kind of the form factor to some extent of the, proteins themselves so that it gives doctors some kinds of, basically some options. Each patient, their different levels of severity and different levels of, and different needs, right? Like some of, some of our kids might want tolerance, some might just want some protection, different goals. And so right now, if you just have a peanut, you don't get to choose, right? You just, you have a whole bunch of kids with different goals and different needs, and you just got this one peanut. And so really what we're trying to do is make these peanuts on some level available in different ways so that it allows the doctor and the patient to decide what do they need and what do they want for the presentation of that peanut. And that, that allows hopefully. The doctor to practice their, their therapy of, food allergy in a way that works for the patient. It is not a treatment for food allergy. It is a peanut that is presented in a different way

Amanda Whitehouse, PhD: 18:01

My brain is taking me to. All of the people that you must have on your team in order to do this. I have no concept of what it must take on the science end to do what you're doing then to be all of these foods because they're, they're just foods, right? There's the peanut is still a peanut. Is it way too much for us to grasp or is there a way to explain it like we're kindergartners

Meenal Lele: 18:23

It takes a lot of people and a lot we work with dozens, dozens of people with, at the company.'cause each person brings a specific skill in that you would need for, you know, to solve a specific problem. But when I'm talking about presentation, you have different kinds of immune cells in your mouth, for example, than you have in your esophagus and you have in your gut. And what we want to do is you can take a peanut protein, for example, and you can put it in certain kinds of liquids, and that will cause the protein to open in a way that allows it to interact. With immune cells in the mouth. And that is different than the way it would be if you were to eat it.'cause remember, when we eat food, it actually gets digested by our gut, the acids in our gut, and, and then when it's presented to the cells in the intestines and so on, it's presented in a different form factor. Another thing we can do with the peanut proteins is almost. A way to think of it is like predigesting it. So if you can take a peanut protein and predigests it in the way that a person who did not have allergy would predigests it before it got to the immune cells, of the intestines, you can change the immune reaction that will happen when that protein. Gets to the, the lower intestine or the upper intestine. And it's weird because it's not, not a peanut, it's still the same peanut. It's really just, you can do some minor chemical processes on it, that sort of, yeah, for lack of better term, I think is maybe like predigestion is the easiest way to think of it. And we have found that when the, it is predigested in this way, it limits the immune response that happens to that protein. having food allergies, not just about the immune cells. There's a growing understanding. Large reason people have food allergy is that their gut linings, Is different. And that's why there's other folks that are kind of seeking microbial treatments like microbiome treatments. That would also affect digestion and things like that. So again, most people when they think of food allergy, you think about the human. You think, well, what can I do to change how they react to the, peanut? And we've just sort of this question of saying, well, how can I change the peanut to change how the human will interact with it?

Amanda Whitehouse, PhD: 21:12

This is fascinating to me. So the output then, once you do all these chemical processes to whatever the food is, let's continue with the peanut. Is it, is it a powdered form o f the peanut that has undergone this chemical process, what's the actual product going to be?

Meenal Lele: 21:28

Yeah, in that case of the, the sort of predigested forms, and we call, kind of call them hypoallergenic forms of these proteins.'cause again, what we've done is remove those epitopes. And I, I can explain that in a second. Yes, they are powders. And they're powders largely because that's a way to stop the chemical reaction basically is if you dry out something and powder it, dehydrate it, you can end the chemical process. And so it keeps it, it keeps it stable at that point. Mm-hmm. Um, and things in liquid because of water or anything that it's dissolved into is a chemical too, right? Mm-hmm. So it, there, there's constantly a chemical reaction happening when anything's in a liquid form. And so a dry form is stable. One of the things that we're doing, as I said, when you're sort of predigesting it, or whatnot, is you change the protein structure in a person who has an allergy antibodies bind to specific points on the peanut. If you remember the COVID, virus, the spike protein is the point where our immune systems would sort of bind to that. Virus. Virus is a whole big thing, right? But we really bind the one spot, one type of protein on that whole virus. And so when we were coming up with drugs and everything, it was all about that point where, how do we change that action at that point? And so food is really similar in the sense that. There, there are technically an infinite number of points on this food, protein one our immune systems could bind to, but they actually really only bind to specific points. And if you remove some of those specific points, not all of them, you can make it so that your immune system almost doesn't recognize the protein and so it doesn't realize to mount an immune response against it. And again, that is really what. Many healthy people do is they, they take, when we ingest food that we're not allergic to, we alter it so that it, by through our digestion, we alter those foods so that our bodies know not to react to them. And that is fundamentally in many ways how our body knows what, what is a dangerous food and what is not. If you think about it. Your gut It's a closed like bag. There's like a tube going from your mouth down, your system, right? And it's a closed system. And all this stuff has to happen inside of this bag. And then finally, when it's broken down enough, these molecules cross our gut barrier into our bloodstream. And only when they're in our bloodstream can they be utilized by all of our cells and move around through our system. Right? But. The form that a food is in when it crosses, or a form that anything is in, and when it crosses, really determines how our immune system responds to it. The things we've been messing around with is how can we change that food protein? Or, or shift it slightly so that when it crosses the barrier for people with allergy, it's doing so in a way that seems benign to that person.

Amanda Whitehouse, PhD: 24:24

To help people connect with this, I think the term that people will understand when they're talking about proteins entering the body when they shouldn't, right. The way the gut works is it breaks those down, but that's when we start talking about Leaky gut, right. Proteins entering directly into the body when they shouldn't be through the gut.

Meenal Lele: 24:41

Yeah. Leaky gut is a. Hand, wavy term, that means I think different things from different people. It is a real phenomenon, but I think there's a lot of argument there because many people, again, are just just talking about different things when they use that term. But let's take the extreme version of it where you literally had holes in your gut and whole proteins were just floating across the barrier and they're completely intact. Whole form, right? Like that would be a very truly leaky gut with like just no processing happening inside the gut. And in that case you have immune cells immediately. Anything that crosses the gut all the time, like all the stuff that we agree to not fight. Mm-hmm. Our immune system binds to it and then the immune system has to basically like look for signals on it. It looks for two different signals. It looks for, is this something my own body made and does it have specific. Combinations of things and, and then it takes that and it presents it and says, this is what I think this thing is. And then our immune system from there decides what to do, like attack it or not. Right? In the case of a whole intact protein, again, that extreme example, it would almost always say like the combination of factors would be there for the immune system to present it to the remaining immune cells, like T cells. Mm-hmm. And say, Hey, this is a dangerous thing. But what I'm talking about a is a little bit different in that, when we have different bacteria in our, in our mouths, in our esophagus, and, you know, through our gut, we break down the proteins and different acids and so they create these peptides and, um, but the peptides, again, the peptides are, are portions of the protein. So that that idea of splitting a protein is called cleaving it and where the protein gets cleaved and, um. How many chunks are created, kind of change based on which bacteria, um, are doing it. How thick your mucus is can change how long it's sitting in the acid. So how, how much, like, you know, like a long laundry cycle or a short laundry cycle, right? Mm-hmm. A long cycle you're gonna get more of the dirt off kind of thing, right? We tell everyone, you know, you're supposed to chew 26 times, which I can't even do, but you're supposed to like chew 26 times before you swallow, right? Same ideas, like, it's like how much is it breaking down, um, before it continues through. Mm-hmm. And so, so again, all of these things are interrelated but at the end of the day, what's happening is that stuff is crossing the barrier. And then based on the structure and size and exactly where it was cleaved, so which peptide chains are passed across to the, immune cells. I'm trying not to overcomplicate it, it's just complicated. You're not over complicated. It's com it's just complicated, right? It's like not a straightforward answer, you know, I, I think people want it to be a straightforward analogy and it's, it's just not that simple. But, um. But those are some kind of basic ideas. The, the basic fundamental thing is that like what many things can change, what gets passed across. Also many things can change, you know, what is the state of the immune cells, like how trigger happy are they and things like that. As they're, you know, as they're making this decision. And, and that's a real piece of it actually is like, you know, we talk about inflammation. And inflammation in a broad sense can be a little bit like how biased is your immune system to. Being aggressive versus not. And again, that's like really a metaphor, but um. But it, but it's not totally wrong. Um, I think, and so when people are in a state of high inflammation and the same exact information is presented, it's like, it's like when you're hungry, you know? Mm-hmm. And someone says something to you, you might have a very angry response as opposed to if you were like, well sated, then you can deal with it calmly. Right. Um, we have hang Exactly. Yeah. So sometimes our immune

Amanda Whitehouse, PhD: 28:33

systems get hangry. That kind of leads us into one of the things that you and I were so excitedly talking about. Obviously this is all tied to. Our gut health, which is a very complicated process. It's not as simple as people think I'm gonna go take a bunch of probiotics. Right. It, it's not that simple. But you and I were taking that conversation into how this connects to our mental health as well. So again, I know it's not as simple process, but what do you want people to understand about how this all ties together in terms of, of that piece of things and the role of gut health in our mental health and wellbeing.

Meenal Lele: 29:08

Well, I would say more simply, there's two pieces to it. One is that if your gut is not in good health, then the probability that you are passing the wrong things across the barrier, or that they're getting passed across the barrier and you're making your immune system is making the wrong choices, if you will, um, that that probability is higher, right? Mm-hmm. So, it seems pretty clear that. Even in a person who has food allergy, if you were able to truly improve their gut health alone, you would make that process of desensitization potentially much easier and, and have fewer side effects. So that's one piece of it. Second piece of it is, again. It's super complex. I'm not pretending to understand it. Um, but we know that the state of our, again, broadly gut health affects our mental state. Mm-hmm. But it's important to understand, I think that we forget it's bidirectional, right? It's an axis,

Amanda Whitehouse, PhD: 30:01

it's a gut brain axis. Yes.

Meenal Lele: 30:02

Yeah. Yes. And so people tend to think like, okay, in that, the way that's easy for me to understand is like when my stomach is upset, if I've eaten something, I'm not in a good mood. But it also works the other way that if you're mentally not in a good place, your gut isn't in a good place. And so that goes back to point one, which is if your brain can almost like make your gut leakier. Right. Um, and then, then you're gonna do worse with treatment or you're gonna be more likely to react even if you're not in treatment. Right? So it, I think it's just such a wild, complex system, um, or interacting set of, of systems, um, that, that the people are working really, really hard to understand today. And I don't think we understand completely, but in that broad sense, in that, in those broad stroke sense, we know those things to be true. And so without. Really understanding the mechanisms of any of this. We can broadly say that if there were a way to have ourselves in better gut health and in a better mental state, those were, those would both be fundamentally a better place

Amanda Whitehouse, PhD: 31:02

from which to start treatment. Right? It's so complex. I think people feel overwhelmed with, not knowing what to do with it or where to go when, when they know it's a thing. We hear about it all the time. But I think what you're saying is, what I want people to understand too is that it's a holistic process.

Meenal Lele: 31:19

I'll give you this. I think there's this really fascinating just because We talked to a lot of doctors doing clinical trials.

Speaker 3: 31:25

Mm-hmm.

Meenal Lele: 31:25

And so this concept, you know, doing an oral food challenge and we often do blinded food challenges. And so when somebody has multiple food allergies, let's say you had three food allergies, right? Egg, milk, peanut, the way they might do the challenges actually have, you do four challenges and you don't know which what, so you don't know if today you're having egg, milk, peanut or placebo. The fascinating thing is if you take. People like this, children, and many of these studies are done in children. The rate at which people react to the placebo is way higher than you'd think. Wow. And that which really speaks to the fact that like, so then you're like, what is that? Is that anaphylaxis? Like that's clearly just a completely psychological response, right? Because they're eating something like tapioca starch or oat flour that they're not allergic to. And so, but they're clearly anaphylax, so Right, right. Real physical symptoms. Exactly. So what is that? And, and so when you're going through treatment. That's really an open question. On any given day, you have a reaction or at the baseline, like are you that sensitive or are you that sensitive just because

Amanda Whitehouse, PhD: 32:26

you're nervous?

Speaker 3: 32:27

Mm-hmm.

Amanda Whitehouse, PhD: 32:28

Or are you that nervous because you're that sensitive and it's a spiral that keeps widening and, and getting bigger and more intense. Right. Totally. It could be a. Crazy negative feedback loop. Yeah. But it's so hard for people to break through that because then when they hear, oh, well if, if it's just anxiety, either you're saying, my reaction isn't real, or I can't just stop being anxious about it. Right? It's not that simple. I believe you. I know it's a part of it, but I can't just stop.

Meenal Lele: 32:53

It's a real thing. Like I will fully admit to like being terrified to go in the basement at night, right? Mm-hmm. I'm a grown person and there's no one in my basement, and like, it doesn't matter that I cycle, I, I intellectually understand that there's nothing in the basement that's going to get me. And like sometimes you cannot make yourself go down those stairs.

Amanda Whitehouse, PhD: 33:13

Right. And that's without, I assume, I mean, I could be wrong, but I don't think you've ever had a traumatic experience or actually been in danger or harmed in a basement before.

Meenal Lele: 33:22

Right? No. No. And if like, if I needed to go into the basement, I could, right. But I'm just like sitting there at night or something, you know? And like if my husband's not home and I'm a little bit like, you know, you kind of do these trade offs. They're like, well. I know there's no one in the basement, but what if there were

Amanda Whitehouse, PhD: 33:38

Right. And it's very real. And I, I just think that's such a good example because then take someone, take our kids or, or other people with food allergies who've had genuinely. A really scary, very dangerous reaction to something to, to try to fix that anxiety when it's so hard. Even just to like, I have this anxiety about the basement that's not even really based on a trauma right. To exactly. To try to tease out a real true danger and the anxiety that follows is so complicated.

Meenal Lele: 34:06

It's really, really hard. And you, and again, we were talking about this, that the crazy thing about food allergy anxiety is that it's not irrational. It's every reaction our children have had has been some random accident. So it's like a completely rational fear actually. So then how do you deal with rational fears? And this is, you know. Same thing, like the hardest I've, I've read somewhere that like the hardest fears to sort of, um, phobias to like work through are like phobias of snakes and spiders and stuff because they're like deeply ingrained in us and that they're rational fears. Like those things do kill you.

Amanda Whitehouse, PhD: 34:44

Yeah. And, and it's true. I mean, I'll, I'll speak to that from my work that it is true and it takes a different, it takes a different approach. You and I could work on talking through whatever's feels scary about the basement and, and, and work through it because it's Right. There's a, there's an unhelpful thought process that's happening around it versus a true actual risk. Um, yeah, I think, I think it leaves us, and not just the people who've experienced it, but us as parents of, of kids who've had that happen too,

Meenal Lele: 35:09

and I will say that that is really one, one of the harder pieces of food allergy treatment as a whole, and I, I'm speaking specifically about, you know, in my own discussions with the FDA or the company's discussions is like, it's very hard to tell sometimes we have these high false positive rates of the placebo, but also like. Why a treatment doesn't work for every person. Right? Because it's really hard, because a lot of people, you might almost need to give them a kind of like, not, it's not a, placebo isn't the right word, but like a, um. A less good treatment, a less strong treatment, almost to like give their emotions a chance to get there. You know, and I, I've, I've talked to many doctors who are starting more and more with trying to treat patients in this very low dose way or use sublingual treatment or other things. We know that they don't work as well as oral immunotherapy, but oftentimes that's not the first problem that needs to be solved.

Speaker 3: 36:09

Right.

Meenal Lele: 36:10

And, um, you know. I'll give you the example of specifically of, so our own doctor, we were talking to him about this and he said, you know, a lot of my patients what I do, this sounds really crazy. He's like, but I will treat their environmental allergies first. And even though that delays the whole process by like a year and a half, but what it does is sort of build up the psychological muscle that allergies are treatable. And when we start with something completely unrelated to their food allergies, and you work through that and it kind of just gets this person just more accepting of the idea that they can have their allergies treated. And so then when you go two years later to try and treat the first food allergy, they're just in a better emotional and psychological place. And that alone

Amanda Whitehouse, PhD: 36:57

makes it more successful. Yeah. And I would add on as a psychologist. Now that person has trust in every person in that facility and the people they see in the waiting room, in the space there, in the routine of driving to that office. All of that creates psychological safety, which then creates real physiological safety We had a great doctor who walked us through the process in a similar way We debated whether to start with slit for environmental or just do environmental shots because he thought the reactivity might actually compromise the OIT outcomes. And I said, if I have to bring him here. Every however often for a shot, we're gonna lose him. He's not gonna buy in, and then we're not gonna be able to do OIT. And so he worked with us to do slit and it was really effective for us for the environmental allergies. You're making a good point kind of, like you said about different approaches with the way that you're, um. Modifying the allergens, right? We have to have different approaches for, for all different needs, physiological, psychological, all of these things are different factors that are important that don't lend well to a clinical trial and clear results, but are important in practice. Right?

Meenal Lele: 37:53

Right. In, in the real world, you need a whole grab bag of different options because each person's journey, and even again, I go back to this, like their goals, um. The goals change over time also.

Speaker 3: 38:08

Mm-hmm. Also,

Meenal Lele: 38:08

right? Like you could have someone who says, well, you know, I just, uh, I don't, I don't need to eat cashews, but I would love to be protected. But then they get a, a lot desensitized to cashew and suddenly, you know, then maybe the end doesn't look so insane. And so now they, they change their goals. Um, and that, that has to be okay because Until we get to some again, until hopefully someone gets to some way deeper root cause explanation or un understanding of how to treat, uh, food allergy and just sort of eradicate it with a pill or something. Mm-hmm. Without thinking about it, um, each person's journey is gonna be different.

Amanda Whitehouse, PhD: 38:45

Definitely. Well, thank you for working so hard on something that's going to add another really important piece to that grab bag of options that we will have to choose from. I feel like there's so much more we could talk about for so long, but, why don't I let you tell people where they can find the Lil' Mixins where, where they can follow you if they're curious

Meenal Lele: 39:01

yes, LIl' Mixins. You can find, um, you know, at target.com and on our website on Amazon, like the usuals. Mm-hmm. Um, in the next couple years, more and more, um, pediatricians will be able to prescribe them and along with other, um, early allergen introduction mm-hmm. Products to their patients. And, um, as far as these sort of altered proteins, our, our goal really is to. Make sure doctors have access to them. Um, you know, like anything, it would not be ideal for patients to try and treat themselves. And so, but, um, our goal there is really to make sure that when doctors want to offer different things to patients, they have that, you know, again, just. Harping on the peanut, they have that peanut in different form factors so that they're able to use it, um, the way they and the patient decide is right. So I think ho hopefully over the next, you know, two to five years, nothing in medicine goes fast. More and more doctors will have, access, to those and the ability to use them. Definitely talk to your doctor about it. We work with a, a number of academic centers now and hopefully get into more private practice soon.

Amanda Whitehouse, PhD: 40:06

Good. Well, thank you for all of that because it's really important and it sounds like it takes a special person with a special combination of experience and knowledge and background, like you have to take on such a overwhelming project.

Meenal Lele: 40:19

It is a, it is an overwhelming project and There are a lot of patient advocates, and I feel what's interesting about this,, entire journey has been that these are patient advocate solutions, right? Mm-hmm. Like if I, I'm, I'm approaching a lot of the problem of food allergy, yes, from the perspective technically what has to happen, But really you're trying to solve the patient's problem, which can be, again, one of convenience or cost or psychological fear or something else, right? Which is generally not how, Products in the, in the medical space are developed. These are, these are real patient advocacy solutions.

Amanda Whitehouse, PhD: 40:50

I love that we need so much more of that and I'm glad that you're on top of it. Thanks.

Meenal Lele: 40:55

I think it sounds like, um, speaking of patient advocacy, you and I might run into each other again soon at in some patient advocacy. Conferences and things and I look forward to

Amanda Whitehouse, PhD: 41:04

talking to you more there. Yeah. Yeah. I hope we keep, continue to cross paths, but thank you for joining us here today and we'll keep people posted on your work in the future as it progresses. Awesome. Thank you so

Meenal Lele: 41:13

much for having me.

41:15

It was so interesting for me to meet Meenal and to talk to her here on the show and hear about the work she's doing to make food allergy prevention and treatment safer, more effective, and more inclusive. So if today's conversation resonated with you or sparked curiosity, here are three action steps you can take to follow up on what you've learned. Number one, Learn more about early allergen introduction by checking out Lil Mixins website, www.lilmixins.com. Or you can find them on Instagram at Lil Mixins. And you can also search online for the guide that was created by food allergy prevention.org and FARE called Preventing Food Allergies in Infants. And I'll put the link to that in the show notes as well. Number two, I'm such a bad podcast host. I had so much I wanted to ask Mele that I didn't even get to talking about her book, the Baby and the Biome during the episode, but I highly recommend it. I know many of you are really interested in all of this research that's unfolding about the connection between gut microbiome, allergies, mental health and wellness overall, and this is a wonderful resource for you to check out about that. It's available wherever you buy books, and it's linked in the show notes. And number three, if you have questions about how the topics that we talked about today apply to you specifically, I want to encourage you to talk to your healthcare team about them. There's so much information out there, more and more coming out every day, and there's still a lot of conflicting information that people are getting about early introduction of food allergens and the benefits of it. It's potential for decreasing the incidence of food allergies and about immunotherapy, how it works, who's a candidate for it. Obviously all of these are individual questions for you to ask your doctor, but I do hope that this conversation has gotten you thinking about them. Thank you for being here., If you're enjoying the show, please don't forget to subscribe and give me a rating or leave a review if you're finding it helpful. the content of this podcast is for informational and educational purposes only, and is not a substitute for professional medical or mental health advice, diagnosis, or treatment. If you have any questions about your own medical experience or mental health needs, please consult a professional. I'm Dr. Amanda Whitehouse. Thanks for joining me. And until we chat again, remember don't feed the fear.