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Gut Microbiome Innovation & Tips : Noelle Patno

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Guest: Noelle Patno

Release Date: 4/1/2024

Welcome to Trulyfit the online fitness marketplace connecting pros and clients through unique fitness business software.  

Steve Washuta : What is the difference between a probiotic, a prebiotic, a post biotic and a psycho biotic? What are the current medical claims surrounding this industry? Are there significant differences across populations on the types of bacteria in our stomachs? We discuss all this and much more in the upcoming episode.  

Steve Washuta : Welcome to Trulyfit. Welcome to the Trulyfit Podcast where we interview experts in fitness and health to expand our wisdom and well I’m your host Steve Washuta, co founder of Trulyfit and author of  Fitness Business 101. On today’s episode I interviewed Noelle Patno, you can find everything about her at Noelle Patno no E ll E pa t no dot PhD on Instagram.  

Steve Washuta : She is currently the Chief Scientific Officer at brunette life. And her focus is on scientific education and research in the area of probiotics and the gut brain access. She has degrees from both the University of Chicago and Stanford. And not only she very well credential, but she’s certainly very well read on all of the research concerning these biotics whether it’s probiotics, or prebiotics, or probiotics or psycho biotics, which I didn’t even know existed.  

Steve Washuta : So it was a great conversation, not only talking down to sort of the more granular level about what these do mechanistically in our bodies, but also from the business standpoint. What qualifications and credentials, does a supplement need two meats, in order to be considered one of these biotics?  

Steve Washuta : What’s the difference between a medical grade probiotic as opposed to something sold off the shelf? It was a fantastic conversation. With no further ado, here’s, well, Pat. No, no. Well, thank you so much for joining the truly fun podcast, why don’t you give my listeners and audience a little background on who you are and what it is that you do day to day in the health industry?  

Noelle Patno :   Sure. Thank you. It’s a pleasure to be here. Thanks, Steve. So I guess I started graduating from Stanford University with a chemical engineering degree in Bath and with honors and distinction. And then I went on to work for Abbott Laboratories in the pharmaceutical world research and development, manufacturing, engineering, etc.  

Noelle Patno :  And then I went on to get my PhD in molecular metabolism nutrition at the University of Chicago, worked at metagenics, Institute metagenics, company for dietary supplements, medical foods, probiotics, etc. And now I’m with Banette life, I’m the Chief Science Officer. And I work on the gut brain axis education, I to handle science and regulatory needs for the company, which focuses on neurological health and mental health needs.  

Steve Washuta : Well, today, the lion’s share of our conversation is going to be around the gut microbiome and all the things associated with it, I think my audience, which is I would say, 80% of people in my audience are personal trainers, people in the fitness industry, maybe some physicians, nurses, things of that nature, and the other 20% or just people who are looking for health tips, just the general population.  

Steve Washuta : So I want to start with more of high level talk to really get people to understand this, and then we’ll go into more granular specifics. But what is the gut microbiome? How do you define it from like a layman’s perspective?  

Noelle Patno :  Sure. So in terms of health tips, though, that you mentioned that this is all educational information, it’s none of its medical advice. I’m not a medical doctor, I have a PhD. In terms of the gut microbiome. We define that as the genes and the microbes in your intestine, quite simply that, and we talked about the gut microbiome a lot instead of just the gut microbiota.  

Noelle Patno :  Because most of the research identifies what is there by sequencing genes. So when you think of gut microbiome, think about the genes and all the microbes there in your gut. And those microbes include not just bacteria, but also other small organisms like fungi.  

Steve Washuta : What is the difference between some of the terminology so a probiotic, a prebiotic, a post biotic a psycho biotic there’s so many these terms now floating around the industry, especially with supplements describe how we can differentiate them?

Noelle Patno :  Yes, so the international scientific association for probiotics and prebiotics, or ice app has actually provided definitions for each of these terms. And even though you may hear them used more loosely and differently from different companies, ISEP has strict definitions.  

Noelle Patno :  And generally those should be the ones that are used and are also globally recognized by some other organizations. So for example, probiotic, it was defined by the Food and Agriculture Organization and the World Health Organization way back in like 2000 2001 2002. And it was reiterated with basically the same definition by the international scientific Association, probiotics and prebiotics. around 2014 or so.  

Noelle Patno :  Probiotics are live microorganisms that when administered at adequate amounts confer a health benefit on the host. So that means they have to be living. They have to provide a health benefit, which means there’s there should be clinical evidence behind it. Now, that doesn’t mean that they have to necessarily modify your microbiome.  

Noelle Patno :  That doesn’t mean that they are just good bacteria that have been found to the microbiome, but that they are live microbes that when you take them living, they actually have a benefit where whatever benefit that was. And prebiotics are not just food for the good bacteria, but they are prebiotics are substances that are substrates that that also are metabolized by bacteria in the gut, not necessarily probiotics, but bacteria in the gut that also confer a health benefit on the host.  

Noelle Patno :  And then there’s synbiotics, which could include probiotics and prebiotics in a complementary or synergistic fashion. And there’s post biotics post biotics are inactivated forms of the live micro organisms and or their components and or metabolites that also provide a health benefit. So in all these cases, think of providing health benefits, so there should be clinical research.  

Noelle Patno :  Then probiotic is live prebiotic is the food for the gut microbes, and then post biotic is inactivated, it’s not live. So could it it could be inactivated cells, or it could be components of those inactivated cells. It might also include metabolites, like the short chain fatty acids like butyrate, etc.  

Steve Washuta : I thought I was gonna get to this later on in the conversation. But I think that that leads into my next question just better is that, how is this regulated? As far as like in the supplement industry versus this being a medical product? You know, if the average person walks down their supermarket, supplement shelves and vitamins, shelves, they’re gonna see these terms all over the place? How do we trust the products? How is it regulated?  

Noelle Patno :  So the FDA, the US FDA, regulates food, drugs, and dietary supplements and medical foods, they do not have a strict definition for probiotics. So it’s up to the company, who is marketing a product as a food, a dietary supplement, a drug, a medical food, to decide is that probiotic going down which of those regulatory pathways, and there’s different levels of evidence that are required for different regulatory pathways and different processes.  

Noelle Patno :  For example, drugs require pre market, pre market approval. And I think the reason that the other categories don’t require the reason that many people don’t think supplements are regulated, is that supplements don’t require pre market approval that the FDA can enforce and does enforce regulations around dietary supplements in a post market manner. So you might hear about companies getting boring letters from the FDA. That’s how that’s one main way in which they regulate the industry in that manner.  

Steve Washuta : Interesting. You know, the the first thing I thought of though, supplements, I know a lot of people looking for like third party tested supplements, let’s say if you have a vitamin C, right, you’re looking because this vitamin C, third party tested. So I know there’s only vitamin C in here.  

Steve Washuta : But I, I would imagine you can correct me if I’m wrong in your industry, you know, the probiotics, prebiotics, all of this, it’s much more difficult because people don’t have the infrastructure to have built out the testing mechanisms for third party so you’re doing the testing in house.  

Noelle Patno : That’s correct. With probiotics, when you are measuring those live microorganisms, the gold standard typically isn’t has been and it’s in the Council for Responsible nutrition, slash international probiotics Association guidelines to measure as colony forming units Cfu colony forming units is usually what you’re going to see, to measure those live microorganisms net now the FDA does require that that milligrams also be specified in certain labels.  

Noelle Patno : But Cfu is how you measure probiotics. That’s that’s the gold standard. And not everyone has a lab that can actually have that microbiology, testing, setup, you know, you have to have the the media to grow and culture those microbes, you have to wait and then you count them under a microscope. Some people will say, Okay, I’m going to just open up this capsule that I bought probiotics off the shelf, I’m going to try to culture and yogurt at home.  

Noelle Patno : And then if I see some bacteria that I think it’s the I think it’s working well that’s that’s not what we do in the lab or in the manufacturing environment, right. We have very controlled conditions that were controlled, good manufacturing practices. And that goes back to what you were saying about regulations.  

Noelle Patno : There are controlled good manufacturing practices that are regulated by the FDA and the Code of Federal Regulations, for food for dietary supplements for drugs, and they’re different for each category. So not only are labels and manufacturing regulated, but also there are certain In the ways that that they’re done in the lab and in these companies that we don’t have from your average household tools, right?  

Steve Washuta : Let’s go back to some of the medical or health claims if you want to call them health claims, or the medical claims that the supplements make, whether it’s a prebiotic or post biotic or whatever, psycho biotic, what are some of the claims made? And then what is the science behind these claims?  

Noelle Patno : So it really depends, right? Some probiotics, they may they may make a claim, like supports gut health, or supports your mood or these different claims, right. And there are some third party organizations that actually evaluate some of these claims in terms of looking at the scientific studies behind those particular probiotic strains, and then providing a guide of like, what’s the level of evidence to support their claims?  

Noelle Patno : And, and then they’re also just from the non commercial perspective, scientists out there who evaluate, let’s say, let’s look at all the probiotics for gastroenterology. There’s a world gastroenterology organization that has provided probiotics and prebiotics guidelines, where you can see they actually specify these are the strains, and this is the level of evidence for irritable bowel syndrome or for these other gastrointestinal conditions, right.  

Noelle Patno : So it really just depends on the product, it depends on the strain. And because because a dietary supplement is for healthy, like not disease conditions, and you’ve always seen those FDA disclaimers that they have to have right that says this product is not intended to cure, treat or prevent any disease. There shouldn’t be any mention of disease.  

Noelle Patno : However, if if the probiotic strain was tested in disease population, you can’t talk about that. But there are a lot of probiotics on the market, or so called probiotics, right? That only list let’s say the genus or the genus and species but not the strain and so you don’t really know what’s there. So a genus would be like lactobacillus bifida bacteria. And then a species would be within that genus.  

Noelle Patno : So lactobacillus acidophilus asked offices and species lactobacillus acidophilus lactobacillus rhamnosus, lactobacillus plantarum, although the naming has changed, so it’s not like a muscle Santarem anymore. It’s like the planting muscles, plant arm. And then with bifidobacteria, you might see bifidobacteria, lactis, Bifidobacterium, Brev, etc. And then you’ll usually see an alphanumeric identifier.  

Noelle Patno : So that might be lactobacillus acidophilus NCFM, lactobacillus rhamnosus, GG, those are some common ones have been around for a long time, like the plenty bacillus Plantarum, ps1 28. Okay. So there are randomized placebo controlled trials for some of the strains, and we could talk about those. But then they’re also just a collection of live cultures or live bacteria in some of these products on the market that they’re calling probiotics.  

Noelle Patno : And you don’t actually know what’s in there, or if it’s actually been clinically studied, or even if the Cfu is still there at the end of expiration, even if it might not even have an expiration or a Best Buy date on the product. So those are some things to look for. And it, it really just depends which probiotic you’re talking about, like what kind of evidence is there going back to your question? 

Steve Washuta :Sure. Well, to stay on that you can pick out anyone or their actual, like, longitudinal, like you said, sort of like double blind, proper studies where they’re looking at lab work, or they’re looking at, you know, they’re taking some sort of samples. And it’s not just like a self reporting. Oh, hey, I think I had a gastro issue. I took this strain, and now I feel better.  

Noelle Patno : Right. So there are many examples. And if you don’t mind, I’ll talk about PS 128. So PS 128, has been studied in many different populations. If we’re talking about a we could talk about autism, we could talk about many other conditions, but I think I’ll talk about autism just because there are four clinical trials for ps1, 28 in autism, right.  

Noelle Patno : And these, there were three of them were a double blind, randomized, placebo controlled trials in autistic children. And they showed benefits in reduced anxiety like behaviors and such. And then one of the trials, one of the four trials was actually a real world study.  

Noelle Patno : So the physicians gave PS 128 the probiotic to autistic children who were already on their other treatment plans. And then they also had other autistic children who were given other probiotics not ps1 28 And then they saw that the children who are given ps1 28x only had better improvements according to the positions versus the physicians ratings of children on other probiotics.  

Noelle Patno : So you see, there’s a mix of the three double blind, randomized placebo controlled trials, plus this railroad study. And that’s nice because then you see, it’s not just happening in a controlled study or and repeatedly and multiple controlled studies, but also happening in a real world setting. There are other examples for other populations, depending on which population you’re interested I could speak well,  

Steve Washuta : let’s go back to that one. I have a few questions on that with that fall into the category that you call a psycho biotic and also as a psycho biotic, specifically a term that you use in your company uses or is that sort of industry wide.  

Noelle Patno : So psycho biotic was actually defined in the literature, I believe, in 2013. So as published, and there’s a professor Kryon is the man who basically does a lot of work in that gut brain access area. So I’ll acknowledge him of course, because these other scientists actually defined the term psycho biotic as basically typically probiotics.  

Noelle Patno : But now it’s expanded to probiotics, you know, you could have probiotics or post biotics that confer a health benefit for basically like psychiatric conditions, which could be got brain related, right. So that’s why PS 128 is considered a psycho biotic because it has this gap brain effect. In preclinical studies, it was shown to increase dopamine and serotonin in the brain, and multiple types of models like stress models, Parkinson’s disease models, in preclinical studies.  

Noelle Patno : And then in actual clinical research, it’s been shown to benefit in autism and the anxiety behaviors and stereotyped behaviors and some oppositional defiant aggression, etc. And not just autism. But also there was a randomized, it wasn’t actually randomized. I forgive me, but it was controlled. It was a 200 person anxiety study so that people had anxiety. And so there was one control arm and then an arm that had PS 128.  

Noelle Patno : And they showed a reduction in anxiety. And then there was also an open label, single arm study in Parkinson’s disease, which showed improvements in the Parkinson’s disease symptoms. So you can see all of these neurological conditions, PS 128, provided a benefit. There’s different levels of evidence. But that’s why we believe that PS 120 is a psycho biotic.  

Steve Washuta : Are there different, or significant differences, I should say, across populations of what our gut biome has. So for example, it’s like if you if you were to look at like Eastern Europeans, compared to what Canadians or something like, are you expecting to see like a particular strain work better with a population?  

Noelle Patno : That’s a very interesting hypothesis, there are differences in the gut microbiomes that have been seen, like globally, especially between native indigenous peoples and more urban environments. So there are definitely theories around how people may respond differently. If they have different gut microbiomes.  

Noelle Patno : There isn’t a ton of research on probiotics for like looking at let’s let’s say we designed an ideal study for that question. We would want to look at using the same probiotic. People in radically different places, characterize all their gut microbiomes at the beginning, give them the probiotic, see how their gut microbiome changed over time.  

Noelle Patno : And then also measure what what’s your particular outcome? You know, are you looking at autism? Are you looking at irritable bowel syndrome? What kind and we need to have the same condition, right? Because actually, in many of these native indigenous populations, they don’t have the same health concerns that we do, they might be still battling infectious diseases more, whereas we may have more autoimmune conditions or neurological conditions or other situations like, then they do so we have to identify the same condition that we’re looking at.  

Noelle Patno : We have to characterize the gut microbiome, and then we have to look at the probiotic. So it would be great to do more studies, where we could personalize those probiotics and really understand the interactions between the probiotic and the gut microbiome specific to those different regions and the different condition of interest.  

Steve Washuta : Have they also done studies or do you believe that this would be useful to look at someone’s gut microbiome at a really young age, let’s say as a toddler, and then again, look at it, you know, later into life because my first thought is a chicken before the egg issue, wherein is the are my food choices affecting my gut microbiome or isn’t My gut microbiome affected my food choices, right?  

Steve Washuta : So like, Have I have I developed the particular strains already, if I’m an Alaskan Inuit, and my my ancestors have only eaten, you know, fish? Or have I now because I started to eat all of this fish then develop the proper bacteria.  

Noelle Patno : Yes, there are greater demands for long term longitudinal studies on the microbiome, I’ve heard this interest in these microbiome meetings for multiple years for over the last several years. So there needs to be more of that type of research done.  

Noelle Patno : What we do know, however, is that there are many strains that are more abundant, typically, at younger ages, like you’re talking about toddlers, etc. Bifidobacterium, the whole genus seems to be higher at younger ages and Bifidobacteria does seem to be lower. In the elderly populations.  

Noelle Patno : There are other strains, they’re also associated with a drop off over age as well. And then there are even some types of bacteria that have been associated with longevity just by looking at differences between different populations that have like longer living people, and, and making some of those comparisons across countries across cultures, etc.  

Noelle Patno : So we do need to do more of these longitudinal studies and individual ones, I think there are some individuals like Larry Smarr, maybe you’ve heard of him who’s done, probably the most gut microbiome samples of any individual I would hypothesize. And he’s really pioneered the personalization of gut microbiome sequencing and analysis.  

Noelle Patno : But it takes a significant number of resources to take that much data and analyze it, because not only has he been looking at the gut microbiome over time, but many of these other markers of health in his blood like calprotectin, in in feces, actually calprotectin would be in PCs, but then blood biomarkers like CRP, which is related to stress, and related to overall health, it’s an inflammation marker.  

Noelle Patno : So there, there could be more studies like that, but we’ll need to probably decrease the cost, just like the the, the decrease in the cost of sequencing has really advanced so much more DNA sequencing that we’ve been able to do and really advanced, you know, the just sequencing the human genome, and then also the Human Microbiome Project.  

Noelle Patno : Once we have cost benefits and cost reductions, then I think we’ll have an explosion of more of this individualized law longitudinal studies over time, there is actually a cool new tool that you can basically just go to the bathroom as normally do, and you take that wipe, and you put it into a little device.  

Noelle Patno : And it can actually process in a very short period of time for DNA and RNA. And so and it’s actually a much lower cost than what I’ve seen before. So once that can become more commercially available and more available to more people, I think we’re going to be able to do a lot more of these longitudinal studies.  

Steve Washuta : I know you don’t do this, but obviously you’ve probably researched this. On the medical side. I think for C Diff treatment, they do something where they take particular strains and do that. Can you talk about that? Are there any other medical based procedures that are currently happening or maybe happening down the road that are similar to that?  

Noelle Patno : Well, so of Clostridium difficile, the recurrent Clostridium difficile that is resistant to antibiotic treatment and keeps blooming in just actually because sometimes they Abadox just wipe out all the other good bacteria has been treated with fecal microbial transplant transplant, which is basically taking feces from donors from Healthy People.  

Noelle Patno : And then processing it to make sure that you’re not going to create other side effects, and use using that as a fecal microbiota transplant to treat costum. Difficile that is an FDA approved medical treatment. There are other indications for which medical fecal microbial microbial transplant has been evaluated, and now they’re even doing like viral transplants. I recently heard of that at a step at a meeting recently, which is super cool.  

Noelle Patno : So there’s a lot of research into more of those kinds of medical treatments and drugs. But like I said before, the beginning that drugs, medical foods, foods and dietary supplements are all different categories. Medical food is a very unique category from a medical perspective, that, you know, it’s still for a disease population or a or a population that has a condition you know, not necessarily disease but a disorder or some other type of condition.  

Noelle Patno : And a medical food is intended for the dietary management of a disease, or a condition. And it’s also intended to be used under the supervision of a physician. And this is a category that the FDA has created to open up some possibilities and not restrict kinds of treatments that could be available.  

Noelle Patno : And I guess I shouldn’t say to you, and because it’s not like a drug, because it’s not treating the disease directly or the symptoms directly, but it is providing a dietary and nutritional support, that can still result in meaningful outcomes for that person’s condition. But is, is rather indirect and maybe addressing specific nutritional components. So for example, there are some medical probiotics that are under this medical food category.  

Noelle Patno : Like there’s one that is addressing intestinal dysbiosis, for intestinal conditions. And then like I was talking about PS 128, in autism and other neurological conditions, we consider that a medical food in terms of addressing these unique needs that are present in autism and Parkinson’s disease, etc. Right. So we see in these neurological conditions, a difference in the gut microbiome of these people versus people who don’t have these conditions.  

Noelle Patno : We also see that there are different patterns in the brain. And in the preclinical studies, we can mimic that with decreased serotonin and dopamine in the brain. And then you see that the probiotic increases the serotonin and dopamine in the brain. So this gut microbiome to signaling pathway is very important. And it could be disrupted in these neurological conditions.  

Noelle Patno : So to support that gut microbiome to brain signaling pathway in a medical food way, that’s that’s adjusting to distinct nutrient requirements where you can’t get that in regular food, you can’t get that in regular diet. But by taking a probiotic, like peace 120 that has been derived from a fermented food, you’re, you’re providing that dietary support for that gut microbiome to brain signaling, which, which supports how the body needs to support neurological conditions and behavior.  

Noelle Patno : And that’s also related to the gut brain axis, I just want to mention a little bit about the gut microbiome to brain signaling pathways, right, because it could be through increasing availability of tryptophan or tear seen which are precursors to serotonin and dopamine. So by by the bacteria in the gut, altering those nutrients, that’s one possible mechanism. Another possible mechanism is immune modulation.  

Noelle Patno : So especially during stress, our immune system has also impacted bacteria in the gut can affect the immune system and different immune signals to the brain, which could affect serotonin and dopamine levels. And then there’s also just the vagus nerve, right? So there’s a ton of signals going through through the vagus nerve, which typically uses acetylcholine as its neurotransmitter for communicating from the gut to the brain.  

Noelle Patno : And there’s so many steps from the gut to the brain that we don’t always know all of those steps. But we do know that ps1 28, when given in the preclinical study does altered serotonin dopamine in the brain. And we also see that in the neurological conditions, there are behavioral and anxiety kind of improvements. So that’s just one example of a medical food, which is still sort of in the medical category, but doesn’t have the same category as a drug  

Steve Washuta : or their concerns or maybe they’re they’ve already been addressed with particular medications used in conjunction with some of these probiotics or prebiotics, or psycho biotics, can they have a, you know, sort of a conflict maybe as synergistically in a good way or a bad way?  

Noelle Patno : That’s always possible. So for example, with the statins, for example, I know that there’s a differential response to statins based on the person’s gut microbiome that has been shown in literature recently, as far as probiotics being given at the same time as drugs. There does need to be more research on this for ps1 28 I gave you a lot of examples.  

Noelle Patno : All those trials actually, those people who were taking ps1 28 and the anxiety trial, they were already on a medication in the Parkinson’s disease trial. They were already on their medications. And in the autism trials, they were already on interventions, but also be aware that in all these clinical trials, they were under medical supervision and a medical food due to medical probiotics included, are intended for use under supervision of a physician.  

Noelle Patno : So if anyone is taking any other treatment that could alter serotonin and dopamine, just like PS 128 might, then they should be under the supervision of a physician as to whether they should even, you know, take such a niche intervention, and to monitor their behavior, their symptoms, etc, to determine continuance discontinuance dosage etc.  

Noelle Patno : That’s always something that that they should be aware of, and to look for interactions because ps1 28 as a probiotic is not it’s not a drug. So it’s not a heavy hitter, it’s not going to make those huge jumps. But there could be some people who are extremely sensitive. And so that’s why it’s always important to deal with a practicing physician who’s very aware of serotonin and dopamine and how to manage these conditions.  

Steve Washuta : This is going to be the hardest question you’ve had so far. So get ready for this one. I know you’re the chief science officer, but I’m going to make you put on your CEO hat or your CFO hat here. What if you woke up tomorrow morning, and they took all of these supplements and they go, guess what? We have too many positive studies here.  

Steve Washuta : None of these are supplements anymore. They’re all going to be classified in as medical. Great. How do you pivot? What are the thoughts about that? Are you worried about that? Are you worried about government oversight?  

Noelle Patno : Are you actually if you’re saying if their data, if their dietary supplements, and they’re going to medical foods, that’s actually an easier transition? But if they’re dietary supplements, and they’re going to drugs? I think that’s where  

Steve Washuta : you’re Yes, that’s where I’m going? 

Noelle Patno : Yes, Well, then you’d have a lot of investment that would be needed to do all the pre market approval because an investigational new drug application and ind takes a lot of paperwork, a lot of money, a lot of investment. And there are companies that are working on probiotics for drugs, like live Biotherapeutics.  

Noelle Patno : And there are other dietary supplements out there that have been in the news, because companies are selling them as dietary supplements. And yet the FDA has started to talk about those particular dietary supplement ingredients as drugs. So this is this is happening. And there are lawsuits and litigation around it.  

Noelle Patno : So it could happen. There are definitely definitely many people working on those sorts of things right now. Yet, that even even the ones that I’m thinking about in the dietary supplement world, I still see companies selling those dietary supplements that are sort of hanging in the balance as to whether the FDA will continue and say this is a drug or whether the courts will decide based on you know, the appeals of the whole industry saying.  

Noelle Patno : Hey, this is a natural product, and it’s a supplement. It’s not a drug. So it’s it’s an it’s an ongoing debate, really, it could happen. And there might need to be a pivot, or there might be more litigation like is happening with some of these other ingredients out there in the market.  

Steve Washuta : Yeah, it’s always intriguing to me, when people have supplements or companies have supplements that are almost overly successful. You look at something like CBD now there’s all these studies out there certain pediatric seizure related things where CBD is very useful for it’s like, well, you know, then that that crosses a fine line, it does, does that become a drug that now pediatricians start to use?  

Steve Washuta : And now CBD can be classified as a supplement anymore. So it is interesting to what the government is going to do if they’re going to step into these situations. But I want to ask you about ratios. Are there specific ratios of micro, a gut biome that we should see in the average person? Like how many different sorts of pockets? Are there millions of different strains inside of me right now, or they’re only maybe four or five, and I’ve 20% of each.  

Noelle Patno : So there are trillions of gut microbes in the gut. And there are many, many, many strains, like most of the gut microbiome studies don’t necessarily even go to the level of strains. They’re identifying bacteria on the genus level, or maybe they’ll go down to the species level, but going down to the strain level takes you know, more cost more time. 

Steve Washuta : What did you say the highest level sorry, so if you say the genus level, what is the what is the ratios?  

Noelle Patno : So there used to be this idea that this ratio of bacteroides Firmicutes was considered associated with health, especially with obesity or or leanness, but that thinking has been reversed by later studies. And there Are other studies where they look at different types. And I don’t think that we have a great idea of saying our ratio is perfect.  

Noelle Patno : There might be some microbiome test companies out there who are still using the bacteroides. To Firmicutes ratio. There might be other microbiome companies who are using other types of ratios or, or just even just highlighted certain genus, right, like, they’re probably looking at lactobacillus bifida bacteria, akkermansia, they call it by temperate tendency, they’re probably looking at these, but it’s really challenging because the microbiome test companies are often using different microbiome test methods than a lot of what the research was using.  

Noelle Patno : And so they might actually have their own proprietary data and their own proprietary standards. And they’re comparing using their own data set, and it’s not published. So we really don’t have a way to verify, validate or test in a transparent manner, right.  

Noelle Patno : There are some studies in the literature like this gut microbiome health index that was used by someone and and this whole group looked at a lot of publicly available microbiome data that was just open source data, it was just publicly available, and they could just download all that data and then analyze it.  

Noelle Patno : And it didn’t necessarily show some of the same patterns that we might have expected from some of these other studies where you generally think necromancy is good. In some conditions, it’s higher than healthy controls, and then particular bacteria and Prince Nitze is typically a keystone biomarker that’s usually thought of being essential and being important, particularly against inflammation.  

Noelle Patno : So you’ll see lower levels of a callback term presidency in some of these inflammatory bowel conditions like I like ulcerative colitis, or else you might even see it lower in colorectal cancer. And then on the other hand, after Mansa Musa Fila, you’ll typically see that lower in some of these metabolic conditions like type two diabetes, and obesity, hypertension, etc.  

Noelle Patno : But that wasn’t necessarily showing up as some of the most important some of the most important species in this got microbiome health index that this one group did. And they they looked at a ton of data, right. But there’s this push toward international harmonization and international standardization, because there is so much variability, not just in the microbiome by itself, but also in test methods, like how you’re extracting how you’re purifying that DNA, and then how, how you’re sequencing that DNA?  

Noelle Patno : And then which reference database are you using to say like this gene means this microbe, there are different databases. So there’s a push toward standardizing this so that everybody is sort of using the same language, so to speak. And I think we need that international standardization so that we can understand what is healthy ratio? What is the goaltender microbiome, we’re not there yet. And there are so many microbes in your gut to look at that I think we still have a lot of research to do in that area.  

Steve Washuta : From a consumer perspective, on our end, you know, I go to the store, and you know, I look at all of the different probiotics probiotics that are available, should I be thinking about this, like, I would think about a multivitamin, wherein I don’t necessarily need to have a problem. But I’m gonna go ahead and use them anyway. Or are you associating each individual strain with just fixing the problem rather than just taking them for overall health and wellness?  

Noelle Patno : So there, there are those two competing thoughts, right, like taking multi strain probiotics as a multivitamin, to help you with all all of these different conditions, or even just to flood your gut with a whole bunch of good bacteria, because maybe you have lower good bacteria because of antibiotics or other kinds of conditions and situations that you’ve had.  

Noelle Patno : And then there’s the idea that, let’s just look at which particular strain or string combinations that could be a pair, it could be five, whatever was tested, has actually shown a benefit in this condition and population. And I would say that most of the scientists, researchers and industry are on board with the specific strain for a specific disease, particularly with the 2018 publication by McFarland and others, that talks about strain specific disease specific probiotic efficacy.  

Noelle Patno : And, you know, that was about five or six years ago, but it’s still showing true today I sap the international scientific association for probiotics and prebiotics, the International probiotics Association. These various organizations are recognizing, look, these are the strains of help for these particular conditions. So that’s what we can recommend from actual scientific evidence.  

Steve Washuta : Tell us about some of your company’s products like Norelli mood and why maybe your company does things differently than other companies. You don’t have to throw anyone else under the bus. But what you may do differently that that some companies do not.  

Noelle Patno : So we’re very focused on neurological health and mental health conditions like like I mentioned, Nirali medical probiotic is the flagship, it’s the original. It’s the Latty plantea bacillus Plantera PS 128. So one of our main differentiators is all of the scientific studies behind the strain, PS 128. Like I said, there are four studies in autism.  

Noelle Patno : There’s actually a study in Tourette’s, there’s a study in Parkinson’s Disease study in anxiety. And then with neurology mood, there’s the probiotic and post biotic combination for stress. That’s the dietary supplement Norelli medical probiotic is the medical probiotic for the neurological conditions. So we focus on providing high quality products, that, you know, they’re, they, they follow the Current Good Manufacturing Practices.  

Noelle Patno : Like I mentioned before, we have the scientific studies behind the strains, we show the evidence, we also have a huge like outreach. So Nirali and Banette life is focused on know reaching out to the community and partnering with them. So not only have we had research on these strains, but we’re also still doing research on these strains.  

Noelle Patno : There are multiple studies on clinical trials.gov right now. And I’m very excited to work with Jack Gilbert, who’s a big microbiome expert at University of California, San Diego, and he’s going to be designing a clinical trial for us. First, the process will be to survey autistic adults to find out which outcomes are interesting to them. And then Jack Gilbert will be designing a trial with those autistic adult outcomes in mind, and testing ps1 28 for autistic adults, because PS 120 has mostly been studied in autistic children.  

Noelle Patno : So that’s the Norelli, medical probiotic side, and in the dietary supplement Norelli mood for mental health because so many people just want to manage their stress better. ps1 28 by itself has been studied in stressed workers. It’s it’s been studied also in areas of physical stress, randomized, placebo controlled studies and triathletes, for example, which also showed an impact on the gut microbiome, interestingly enough, and the heat killed or the heat treated PS 23.  

Noelle Patno : The post biotic in there has been studied in a randomized placebo controlled trial in stressed nurses and showed an improvement in their stress, perception and their mood, etc. So and even also with the lowering of the stress hormone cortisol. So we have preclinical studies and clinical studies behind these probiotics and post biotics, we’re continuing to advance research.  

Noelle Patno : We do stability, testing our products, we control the manufacturing conditions. So we have all of these mechanisms in place to provide quality and efficacy. And then we have our education on our website. We also have our community outreach. We work with culture city, which provides support for sensory needs. And we just, you know, talked at a conference recently, we’re talking about South by Southwest.  

Noelle Patno : I moderated a panel where we were interviewing autistic individuals and then also talking to researchers, how do we bring the autistic adult perspective to further autism research and that’s why we’re doing this new trial with Jack Gilbert. Like I said, Nothing about us without us is the tagline. So we want to have the best science and we want to have the community outreach to support people with neurological and mental health conditions.  

Steve Washuta : Now all this has been fantastic information for my audience. Why don’t you let them know where they can find more about your company, the supplements and then also where they can reach out with any questions. 

Noelle Patno : Sure, yeah. The NAD life B and E D L I F e.com Has the neurology mood supplement for mental health, and then also has Nirali medical probiotic for neurological conditions. You can contact with customer service for any questions. We have Instagram. We have Facebook. And let me know if you have any other questions. 

Steve Washuta : I’ll put all the links in the description. My guest today has been Noel, Pat. No, thank you for joining the Trulyfit podcast.  

Noelle Patno : Thank you, Steve. It’s been a pleasure.  

Steve Washuta: Thanks for joining us on the Trulyfit podcast. Please subscribe, rate, and review on your listening platform. Feel free to email us as we’d love to hear from you.

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