Part 2/2- The Murky Underworld of Infant Probiotics, with Evolve BioSystems

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March 12, 2021

How do you know if a probiotic is right for your infant? What is the BEST one? How do you give it to them?

This is Maureen Farrell and Heather ONeal. And this is The Milk Minute. We’re midwives and lactation professionals bringing you the most up-to-date evidence for all things lactation. So you can feel more confident about feeding your baby, body positivity, relationships, and mental health. Plus we laugh a little or a lot along the way.

So join us for another episode. 

Heather: Welcome back to The Milk Minute Podcast everybody. We had just a few more questions for our friends at Evolve BioSystems. 

Maureen: Yeah. We’re here for part two. And you know, last time (part 1 of the interview) when we said goodbye, we talked about how we’d get into a little bit of the practical bits, the nitty gritty, like, you know, we really covered a lot of the what and why, but we’re here for the how. 

Heather: Yeah. Yeah, for sure. 

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Heather: So let’s start with the parents that are, you know, crying to their pediatrician because they’ve got all these issues with baby that they just can’t resolve. And maybe their pediatrician doesn’t know anything about probiotics or really any options other than, maybe it’s your breast milk. So let’s talk about what research parents can trust.

So when they’re going to do this research themselves, what kind of research are they looking for? What quality? And talk to us a little bit about your research quality. 

Dr. Tracy Shafizadeh: Absolutely. So, you know, what’s interesting is most of the times that we’ve chatted with moms or dads or clinicians that have used Evivo  they came to us through an internet search, looking for symptomatic relief or some kind of problems with either their baby or a baby that was in their care was experiencing.

And we at Evolve actually think of it as, that’s way down the pipe. When you already have a problem. We think of it almost as, we need to be thinking about getting B. infantis into babies before there’s a problem because the lack of the infanticide often is what leads to these symptoms and leads to these issues that moms are having. Whether it’s diaper, rash, or colic or gaseous or fussiness or sleep or behavior issues.

And so when you go to your pediatrician and your pulling your hair out and you haven’t slept in weeks and your baby seems miserable, at that point, they’re scrambling. Both mom and provider are looking for a symptomatic relief and something to solve the problem that you leave. So, what we’ve done at Evolve is we’ve actually on the Evivo website, we have created a way to talk to your pediatrician well in advance of being in the midst of a colic crisis.

And we have a one page downloadable PDF of how to talk to your pediatrician or healthcare provider about the infant gut microbiome, about B. infantis and about what role it plays and how and when to use it. And as part of that, it’s intended to just start a conversation with your pediatrician early so that you’re not going in a state of desperation because you just don’t know what to do and you’re at your wit’s end.

The good news is, if you do find yourself in a state of desperation and at your wits end, we also are seeing symptomatic relief when you give Evivo to a baby that has severe symptoms of colic or severe diaper rash, or really issues with sleep behavior. So what we really like, both clinicians and parents to be thinking about is get B. infantis into your baby as early as you can. 

And then if you also are experiencing issues that are symptoms of lack of B. infantis, then Evivo also has a role there. So that the answers kind of, how do chat with your pediatrician about it. When you’re evaluating the different products that you have available to you we think about it as kind of three legs of the stool. Stool and pun intended. They’re three legs of the stool. We need to make sure that we are thinking about the right strain of bacteria. So what are appropriate for a baby that’s zero to six months old and consuming breast milk. It is probably not going to be a bacteria that thrives in an adult gut who’s eating a plant and meat based diet. 

So the right strain of bacteria. And the right food for that bacteria. So in this case, B. infantis is the right strain and human milk is the right food for that bacteria. And then the third leg is at the right time. So it doesn’t make sense for us to take Evivo as adults, because most of us are not consuming high amounts of human breast milk in our diet.

So it has to be the right strain, the right food at the right time. And when you get those three things right, whether you’re talking about an infant, a toddler or an adult, you’re going to be able to piece together the scientific literature and the evidence and the products that are available to fit the right product to the person that you’re looking for a probiotic for.

Heather: Yeah. And also your research has been published in some pretty big journals. I mean, when parents are doing research, I get sent articles all the time from like poop.com. Like a parent finds this article that just terrified them. And they’re like, have you seen this, are you kidding me? And I’m like, okay, this is from poop.com.

Like we cannot take this seriously. So I’m very glad to know that your research has been published and peer reviewed. And you know, this is, you know, like I told Maureen, when I first called her, after I found y’all, I said, all right, Hear me out. I know we don’t usually talk about products, but I really feel like this is one of the most important things that we could possibly talk about right now.

And we’re going to learn so much and she was like, in true Maureen fashion, all right. Yeah. 

Maureen: Well, you talked to my ear off for like 40 minutes straight about it and I was like, okay, sure. Sounds great. Heather’s really passionate about that. I mean, if you’re that excited, you could probably just have said a single sentence that excited and I would’ve been like, okay, sure.

Heather. Listen, I trust you. If you’re that excited, I’m going to love it. 

Heather: So I don’t think we’ve talked about this before, but where, how did you get your strain to do research on? 

Dr. Tracy Shafizadeh: It was actually isolated from the stool of a breastfed baby that did indeed have B. infantis. We feel like that is the absolute most natural and authentic version of a probiotic strain that we could imagine having acquired. And we’re very proud of that. 

Heather: I bet. I bet that baby’s really proud. The proudest poop it’s ever taken. 

Maureen: Yeah. Well, and you know, like we, we read a lot about like fecal transplants for, you know, all kinds of different gut diseases and I’m like, yeah, yeah, we gotta use that healthy poop we have, you know. Totally. Yeah. 

Heather: Well, I think a lot of us know just enough to know that probiotics are good and we should take them in concert with antibiotics to make sure that we don’t get the diarrhea from antibiotics. That’s pretty much as far as it goes, I think. As far as a thought to probiotics, but it seems like in addition to that, parents are also getting prescribed probiotics from pediatricians. Like, Oh, just throw this at it and see if it works for random gut issues. 

Maureen: Or they’re told to give their baby probiotics, period. Not like a kind, not where to get it. Not what to look for to make sure it’s a good kind of probiotic. 

Heather: Right. And then we also get the question from parents. How long do I have to do this? Like their gas has been a little bit better. I guess? Do I just give them probiotics forever? So can we clear up some of the other probiotic myths out there and why B. infantis that you work on is different than just a regular probiotic that you take when you take antibiotics?

Dr. Tracy Shafizadeh: Yeah, maybe I’ll start and then Bethany can weigh in as well. I think this, this exact question is so spot on that we’re even talking about pediatricians saying, probiotics. Sure. Give it a try. It’s not,  even pediatricians don’t know enough about it to actually say, this strain of bacteria would be really good for this particular symptom that you are trying to resolve.

And I equate it to the way we talk about food or the way we talk about medicine. We would never say, go eat some food. It’s probably good for you. We would say there are good foods and there are not great foods out there and they all do different things. And now we have a whole area of science dedicated to understanding the nutritional science behind foods.

Dr. Bethany Henrick, Ph.D.: Yeah. Or go take medicine. 

Dr. Tracy Shafizadeh: Yeah, try a drug. A pharmaceutical drug that might help you with that. We don’t talk about it that way. We know exactly the details of nutrients and pharmaceutical drugs, because we know exactly how they’re supposed to work, what they do and what the clinical science says about them.

We haven’t achieved that with the probiotic nebulous cloud that we talk about. And so therefore, both clinicians and parents are really confused and they’re disappointed often that they’ve heard that probiotics are good. They try one, they don’t get much results and they wonder why is it?

Is it the brand that they bought? Is it it’s just not working for me? And that’s where we really want to elevate the entire category and entire area of science too. Let’s not talk about food, drug probiotics. Let’s talk about specific bacteria, what they’re supposed to do, how they work, and let’s do some rigorous scientific studies to show exactly the mechanism of action.

So that’s what I would say is we have a little ways to go on the education so that both clinicians and parents can make better choices. The good news is the infant gut microbiome, which is only about the first six months of life, is pretty straight forward. It’s the only time in our lives until maybe very, very end of life, where we have one single food source.

And we have very few bacteria that are able to consume or utilize that food source. And there are very specific milestones happening in a short amount of time. So we feel like that’s becoming much more manageable. Once you introduce solid food and plant based fibers and other meats and other things, your microbiome changes dramatically.

And there’s all different types of nutrients. And everybody’s microbiome looks a little different. It’s still a very much an unknown area, and there’s a lot more research that needs to take place for later in life. Bethany do you want to add anything? 

Dr. Bethany Henrick, Ph.D.: I think you did a great job. I mean, I don’t know where I could add. The one thing I guess I could add is that unfortunately, a lot of clinicians aren’t up-to-date with the most recent literature. And this field is growing by the day. What we’re learning about specific strains of bacteria and how they impact human health is not changing, but we’re adding to it every day.

There’s new data from our group and others. And so clinicians often don’t have the time or feel the need because this probiotic board has kind of muddied the waters for different strains of bacteria. So I suggest that if parents are really interested that they have to do some of the research, they have to look at some of the papers.

And often it’s written in a very technical manner. But there are good takeaways from websites of a probiotic manufacturers. From this podcast. There are ways to get that data and I wouldn’t necessarily always rely on the clinical to know what’s best just because it’s such a new field.

Maureen: Right. And, and there’s even then like more to consider. Say, you figure out the exact strain you need to deal with your, you know, eight month old baby’s diarrhea. You know, then you have to find out, okay, wait, it matters how this has been processed and handled and stored up until the point that I’m purchasing it at the store.

You know, can you give us just a little quick summary of say, say you are buying something from the store, you know, are we looking for refrigerated stuff? Is it okay if it sits on the shelf? Liquid? Solid pills? Do we have conclusive data on that? 

Dr. Tracy Shafizadeh: That’s a really great question. And if you walk into whole foods or a CVS there, it’s a whole wall of probiotic choices now. It’s not one or two, it’s hundreds. The way we think about it is bacteria are living organisms. And if you set them on a shelf at room temperature for months, the likelihood that you are going to have the number of viable, working, bacterial cells, by the time you consume it, months, a month or more later, it’s probably pretty low.

So the way we think about it in the ways that we manage and handle the products that are available through Evolve specifically Evivo, a baby probiotic, is it’s cold shipped. The entire process from fermentation and manufacturing and packaging and shipping and getting to mom’s doorstep is temperature controlled. 

And it’s cold shipped. It arrives at your doorstep cold. You immediately put the packets of bacteria in the freezer or the fridge. And you only take out one at a time as you need it each day. Mix it with a small amount of breast milk or water or whatever you’re feeding your baby.

And you just use a dropper or your finger to get into baby’s mouth. Therefore, the amount of viable or live cells that you see on the label is actually what you’re feeding your baby versus the theoretical number, but after months of sitting at room temperature. You don’t know what you’re going to get at the end.

Heather: Yeah, that makes total sense. And I appreciate you saying that for our listeners, because I think it can be really overwhelming for people when, you know, you’re confronted with the wall of probiotics.

Maureen:  It’s overwhelming for me, you know, and I like, know that much more than most people about it. And you stand there and you’re like, well, yeah, I guess I could read every label. Maybe. 

Heather: Right. And when you’re tired, you don’t have time for that.

Dr. Bethany Henrick, Ph.D.:  For the infant microbiome. I will add that you don’t need the wall or the selection. So I pointed out that human milk, you know, evolved to feed humans. But the other thing is babies you know, in the very best of settings are exclusively breastfed for the first four to six months, right?

So we really only need one strain of bacteria that can consume those complex sugars that are in breast milk. To date, we’ve only found one strain of bacteria that does that, and that’s B. infantis. So it makes the choice for parents much easier for their infant. And it probably, I mean, more research will come, but all of the most recent data point to the fact that that first six months is critical for immune development, metabolic set point, your brain. The brain doubles in size in the first six months. 

So we have an opportunity. And the simple fact is there’s one bacteria that colonizes breastfed babies, because it’s evolved to consume the complex sugars we feature most makes the choice much simpler.

And it’s really important that you do intervene in that time because babies no longer have it. And it is linked with all of these major health advantages. You know, the immune programming, the metabolic setpoint and brain development. 

Heather: I think that you just really hit the nail on the head as far as what parents are looking for. And I think most parents treat their clinicians as that person who’s supposed to give them the one answer they need. And I think when a parent is faced with a diaper rash that they can’t cure, even though they’ve tried every single thing under the sun. Or the colic that won’t stop or the infant that won’t sleep or, you know, gas that’s just like, where is this coming from? My baby’s exclusively breastfed. And they go to get the one answer they need. 

Maureen: The one answer they need from someone who also doesn’t have a lot of training regarding breast milk, breastfeeding, like any of that, because, you know, you ask a pediatrician and they’re like, well, I know about babies, you know, and I know they should eat breast milk and that’s kind of the extent of that.

Heather:  But because they’re only eating breast milk, a lot of times we hear, well, my pediatrician told me that maybe my baby, my breast milk, just isn’t good for my baby.

Maureen: Right. Or maybe well, let’s try formula and see what happens. Or, you know, have you tried cutting dairy out of your diet? Without even asking the parent, like how much dairy do you eat? Is that something that you can even do? 

Heather: Yeah, these really upsetting, interrupting, events. Life events and interrupting the process of colonization of the microbiome. And we usually, then they call us. You know, we’re like the second or third in line, when people are already bawling. And they’re like, what do I do? They told me to stop breastfeeding. And we’re like, okay, first of all, no. Right. We’re not doing that. 

Maureen: Take a step back. Why did they say that? Like, does your baby have galactosemia? 

Heather: Yeah. Super rare disease. So having this as the very simple, scientifically proven, let’s try it thing, is going to really make people feel so much better. Because I think when the pediatrician say probiotics, sure. Give it a try. It’s because there’s really nothing else you can do for those babies. Other than to remove things like breast milk, or have you tried not wearing a diaper for the next week?

And the mom’s like, really? Okay, no diaper? We’re doing that now? Yeah. 

Maureen: Well that’s all, that’s all you’re doing. Cause I’ve, I’ve been there. I’m like, okay. We just sit on a waterproof blanket for two, two weeks. Okay. Great. 

Heather: I don’t know if there was a question in there. 

Dr. Bethany Henrick, Ph.D.: Well, no, but Tracy actually has an answer to that, I think, right Tracy, about diaper rash?

Dr. Tracy Shafizadeh: Okay. So I will claim this as my second favorite part of the story. So diaper rash. How many of us have been told by our pediatrician that it’s because we eat acidic foods, that’s what’s causing the diaper rash? So stop eating citrus, stop eating tomatoes, stop eating anything that might acidify or burn baby’s butt. The irony there is it’s exactly the opposite.

So Bethany described the pH of the infant colon and the colonic environment and the healthy breastfed, B. infantis colonized infant actually has a slightly acidic environment in the gut, which actually makes it a little bit more acidic pH of the stool of the feces. Well, the biochemistry there is so amazing because if the stool pH is slightly lower, so slightly more acidic, it actually stops the activity of enzymes that break down the skin. 

But if you allow the pH of the stool to get higher, closer to six, because there’s pathogenic bacteria, it activates those enzymes that break down the skin barrier. So it’s the exact opposite. You want baby’s stool to be slightly acidic. Therefore the enzymes that break down the skin are neutralized and there’s less diaper rash.

And we now see this both with when we poll moms that are using Evivo with their babies. Over 70% said they saw an improvement in diaper rash either immediately or within the first week. And then we also talked to clinicians that say, this was an issue, whether it’s hospitalized infants or pediatricians who see office-based patients, we couldn’t find any way to get rid of this diaper rash but when we corrected the microbiome, it was almost immediate that we saw relief in the diaper rash. 

So, I mean, I just love biochemistry and when it answers the question, it’s like, I love it. So it just makes sense. 

Dr. Bethany Henrick, Ph.D.: To add to that. We actually did publish a paper yesterday showing that we had a significant reduction in diaper rash. So, yay! 

Heather: Well, congratulations. That’s absolutely incredible. 

Maureen: And it’s just, it’s refreshing. We’re like, Hey, let’s use science to figure this out instead of giving parents, one more thing to worry about that literally has nothing to do with the problem. You know, you hear pediatrician say that and you’re like, do you remember how the body makes breast milk?

Like, those things aren’t connecting. Like if you’re eating some acidic foods as a parent, that’s not, it just blows my mind how far of a disconnect there is then between that recommendation and physiologically what happens in the lactating body and then what happens in the infant body. All the way down to that butt. You know, it’s astounding.

Heather:  All the way down to that butt. That’s the title of this new episode.

Maureen: But you know what, let’s jump into poop because I, now we’re talking about it. Let’s get into it. I love talking about poop. You know, so yeah, diaper rash is one thing, but literally the number one question we get from parents is, is this poop normal?

And we get, you know, our clients love to text us poop pictures at 3:00 AM when they’re freaking out and they haven’t slept in two weeks. And people that we work with on Facebook love to post poop pictures.

Heather:  We’re thinking about making a coffee table book of just poop pictures. 

Maureen: Maybe we should. Yeah. Right. I mean the range of infant poop, texture and color is rather large.

Heather: And the number one question, is this blood? Do you see microscopic blood in here? And I’m like, well, let me get out my microscopic glasses.

Maureen: Yeah. We’re going to look for that. But yeah, let’s, let’s dive into like, can we start with what normal, breastfed poop should look like when we have an infant who has the right microbiome? 

Dr. Tracy Shafizadeh: I would buy that coffee table book if you did produce it, so definitely work on that. It’ll be on my coffee table. So I think the one thing I really want to focus on in answering this question is not as much what it looks like, but more about frequency and consistency. Because if you think about that, 15% of the nutrients in breast milk are HMO’s that are indigestible by the baby.

And you need B. infantis to digest that 15%. If B. infantis is not there, those HMO’s get excreted through the stool. So we can see that. When we study the stool of baby’s colonized with, and without B. infantis, you can see significantly more, 90% more, HMO’s in the stool of babies that don’t have B. infantis and aren’t utilizing it.

And when you restore their B. infantis levels you see, or you don’t see very much HMO at all coming out in the stool. So that’s great. That means it’s being utilized. That means 100% of the breast milk is getting utilized by either the baby or B. infantis. So we can see that quantitatively. But if you also think about, if you are nursing every two hours around the clock, about 15% of what baby is eating is coming out in its diaper. You can imagine there would be way more poops per day.

And what we also know about HMO’s are that they are what we like to call osmolytes and the osmolytes are compounds that actually carry water with them. So if you’re pooping out 15% of every nursing session that you have as a baby and carrying water out with it, imagine how many more loose watery stools per day a baby that’s not utilizing HMO’s would have versus a baby that’s utilizing those HMO’s. 

And maybe they would only have one or two soft, well-formed stools per day. And that’s exactly what we saw in our first clinical study that we did with the B. infantis EVC001. Babies that were colonized with B. infantis were having one to two soft, well-formed stools per day versus five to eight or more loose watery stools per day in the babies that didn’t have B. infantis. 

And that, if you just think about loss of nutrients, exposure of the diaper area to feces, there’s no question why you would imagine that a baby not only has a different pH of the stool, but also just exposure to all of that loose watery stool. And so I would say, we are all told, breastfed babies have up to 10 loose watery stools per day. True. Because 97% of babies don’t have B. infantis. But if we go back to what a baby that has B. infantis looks like, one to two soft, well-formed stools per day is very reasonable. Bethany, did you have anything?

Dr. Bethany Henrick, Ph.D.: The only thing I’ll add is when babies are breastfeeding and colonized with B. infantis, they have what we call golden poops. So their poop should not have blood. It should not have mucus. It should not be green. It should be this golden yellow color. And that’s a healthy poop with very little smell.

So as soon as you get that smell, that can suggest that there’s pathogenic bacteria in there. When you get the mucus, that suggests that the mucin layer of the gut is being eroded. We actually have a published paper that showed babies that were colonized with B. infantis EVC001  had a protected mucin layer.

We could actually quantify the amount of mucin that they were pooping out. And what was the final thing? Oh, the blood. The blood is indicative of enteric inflammation, which enteric inflammation is driven by these pathogenic bacteria. So all three of those things you don’t want to see in your baby’s poop, you want to see a golden yellow color.

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Maureen: Do you have a specific well-researched reason for the green poops? Because you know, these happen. Most babies get them every once in a while. Sometimes it’s persistent and it’s something parents really freak out about. And since we, you know, as far as our education goes, we don’t have well-researched reasons behind it.

I try to just calm parents down as much as I can because you know, most of the time it just goes away. But, you know, do you know why, why does that actually happen? 

Dr. Bethany Henrick, Ph.D.: I don’t have a specific answer to that. We haven’t researched green poops, but I’ll add that to the list. 

Maureen: I would love that because you know, parents always ask and I’m like, just give it a couple of days. It usually goes away. Probably it’s nothing you did. Probably something totally out of your control. And if your baby has no other symptoms of anything being wrong, like, calm down. It’s going to be fine. 

Heather: Well, after this last answering of the questions that you guys just did, there are a lot of parents that are freaking out right now.

Maureen: Oh yeah. 

Heather: While listening to this, parents that might be out of, which is fine, like we’re really getting nitty-gritty and we’re gonna not leave you hanging, but the parents who are still in that first three month window, they have access to Evivo. So they could go get that, get it shipped to them. They could do it. They could tell us all about it. We would love to hear about it. 

But the parents who are like, crap my baby’s four months old, my baby has mucusy stools consistently and gas. And what can those parents do? 

Dr. Tracy Shafizadeh: Yeah, we get this question a lot. The more we understand about the developmental milestones in those first six months to 12 months of life, the more granular we get about, Oh, well we would like babies to be colonized from day one because of all these benefits that we’re seeing.

But we tell parents that as long as baby is consuming some amount of breast milk, which to Bethany’s point, could be up to three years, that there is a benefit to having the right bacteria that can metabolize breast milk in baby’s gut. Although you may have missed that first 100 days of some of the immune programming. Immune programming does not stop at the three months mark.

And think of all the pathogenic bacteria that can’t thrive when B. infantis is happy and colonized in the infant gut. So you can continue to give that protective environment in baby’s gut long past that three months mark. So as long as baby is consuming some level of breast milk, it makes sense to pair that with B. infantis.

So I wouldn’t worry about having a four month old or a six month old or an eight month old. It went once baby is done consuming human breast milk, and they’re only on an adult diet, if you will. B. infantis plays a lesser role, it’s not going to colonize the gut and that’s the normal development of the microbiome is moving away from a breast milk diet, into a plant-based and, and beyond diet.

And so once the breast milk is no longer part of the diet, it probably doesn’t make a lot of sense to try to introduce B. infantis at that point. 

Maureen: You know, I just had a whole thought thing I’m going to talk about, so just ride with me for a second. But, you know I was thinking about my own son who was, you know, this colicky baby and diaper rash, and he didn’t sleep well.

And all of that. And I breastfed him past three years, you know, anyway, I was thinking about all that and thinking, you know, there’s probably not a lot of benefit to now that he’s five years old introducing this into his gut microbiome, but what if he had a, you know, a body, that had a uterus and was planning to have a baby at some point?

Is it something that, I mean, you probably don’t have research on this yet. You know, it’s only been five years that you’ve been researching. But would there be a benefit to an adult who’s planning to reproduce and birth a child to then recolonize themselves before that? 

Dr. Bethany Henrick, Ph.D.: Tracy’s is that me? Okay, great. So yeah, we actually get this question quite a bit, especially for expectant moms.

Why can’t I just take it and I’ll pass it through when I have the perfect vaginal birth? The problem is, even though we plan for having these perfect births, they don’t always happen. There’s emergency C-sections. You find out your GBS positive, you know, right before you give birth. And you expect to breastfeed and sometimes breast milk doesn’t come in.

So there’s no harm in that in an adult. And when I say that, I mean, anyone past the age of probably two or three, when they stopped consuming breast milk, taking B. infantis, but it won’t colonize the way it colonizes infants for two reasons. There’s a founder effect. The founder effect is in microbial ecology is when the first bacteria get there and they kind of set up their, their home. 

That’s the founder effect. It’s harder to get rid of those bacteria. And the second piece is after about age two to three, the research shows that you can’t really change the composition of your microbiome.

So even if you are taking it daily there is a chance you could pass it on to your babies through a vaginal delivery, but it’s a lower chance. So instead of taking that risk with all the other risks of antibiotics and, and possible C-section, we just give it directly to baby. Because we can guarantee that when baby takes it, it’s going to proliferate and it’s going to colonize that baby.

And actually that’s an important part of all of our studies. Every baby that receives EVC001 B. infantis, they all become colonized with that strain of bacteria, which no other probiotic can say. There’s sometimes when you give probiotics, people do not become colonized and our product colonizes whether you had a C-section, vaginal delivery, what have you? It colonizes every baby that it’s given to. 

Heather: Cool. So it’s a powder, correct? It comes as a powder form and you can mix it in breast milk, but  what if they’re not pumping and they’re not able to express milk for some reason? Is there another way to get it into baby? 

Dr. Tracy Shafizadeh: Yes, you are correct that at-home use of Evivo is in a powder form. So the bacteria is in these little, tiny single-serve sachets of powder that you take one out of the freezer each day and you tear it open. You pour the small amount of powder into either the bowl that comes with the Evivo or you can use whatever mixing bowl you have at home.

It’s very small. It’s a very small amount of powder and the goal is to get it into kind of a loose paste. So you can either do that with expressed breast milk, three to five milliliters of expressed breast milk. Or a few drops of water and really what you want to do is just get it into a form where you can get it into baby’s mouth and it’s not too thick.

And we see moms either using the small little dropper that comes with the Evivo product and taking the dropper and just putting it into the side of the cheek of the baby. Or some moms find it easier to just use their finger to get it into baby’s mouth or putting some of the loose paste onto their nipple and then nursing as usual.

So the goal is really just get that powder mixed well into a liquid and then get into baby in whatever way works for you and baby. Whatever works during your day. 

Maureen: Yeah. I love using what I think of as nipple administration to get medicines into baby, because especially that first week, like if we’re putting syringes and droppers and spoons into their mouth and we’re not careful, like I’ve, I’ve definitely seen, you know, babies just develop aversions to having things near their mouth or in their mouth. 

And, you know, they’re so tiny. But that’s such a nice way to get something in there that’s gentle with the baby. It works with breastfeeding. And it’s nice to know that that’s an option for this for sure. 

Dr. Tracy Shafizadeh: One more thing I would like to add is when you bring your baby home and they are a few days to a few weeks old, the volume of three to five milliliters might just be way too much. And so the idea is just get a few drops in there. Think of how many billions of bacterial cells are in that powder.

We just need to get a little bit in there every day while you’re starting to colonize the intestines. So even if it’s just a few drops or using your finger with just a small amount. You have not failed to administer the appropriate amount if, you’re doing great. And then tomorrow you can do a little more and as baby gets older and can tolerate higher volumes, you can do the whole three to five mils. So really just want to encourage moms to, a little goes a long way.

Heather: So how many administrations is it before they’re they’re done and colonized? 

Dr. Tracy Shafizadeh: Yeah. So what we do is we actually sell Evivo as a one month package. Because that’s what was used in our original clinical trials of colonizing babies with Evivo. And because we saw such great effects with one month of administration, that’s the unit that we sell to moms now and dads and, and caregivers. Beyond that, there are many parents that are saying I don’t ever want to go back to where I was before. I am going to continue to give Evivo as long as my baby is consuming breast milk and they continue and you can buy one month refills. 

But we would say the bare minimum is let’s get that one month of colonization of B. infantis into baby. And if you elect to continue after that, there are ways we have it set up to where you can easily order a refill. So one month would be the kind of minimum administration. 

Heather: That sounds easy enough to me. Yeah. Oh, and they don’t need a prescription for this, correct? They don’t need to like, get their provider on board for this. 

Dr. Tracy Shafizadeh: No, we really highly encourage moms to have a conversation with their pediatrician or their trusted healthcare provider, just so that they feel confident that they are making a decision and making a choice that their clinician supports. But this is not a prescription product. This is something that they can order either from Evivo.com and you have different options of how much at one time do you want to purchase, how little, but that all comes cold shipped. It’s also available on Amazon. So either way, you can easily find it, easily order it, it arrives within a few days, cold shipped. Should be very, very easy for parents to get. 

Maureen: So, you know, we’ve talked a lot about in this episode and the last one, all of this amazing, well conducted research that you guys have. So what’s the barrier to letting parents know about that? You know, I didn’t know about this until Heather read some random article and, you know, from there, are there marketing challenges? Are there FDA challenges? Like what are the barriers?

Dr. Tracy Shafizadeh: A great question. We feel. Very confident that the science that we are generating and that others in the research community are generating on the importance of B. infantis is irrefutable. And we feel like the science speaks for itself. However, how many of us are reading peer reviewed papers on a regular basis? Very few of us, even those of us who are clinicians. Nobody has time to read through the literature every day on emerging topics. So our biggest challenge is educating healthcare providers and parents so that they can weed through what we call the murky underworld of probiotics, which is full of pseudoscience or complete lack of science. 

And that’s really been our biggest challenge. So we love educating people like you, midwife doulas, lactation consultants, pediatricians OBS, people who are in the business of helping navigate moms go from pregnancy all the way through delivery and then caring for their baby so that they can weed through all of the junk is out there. 

So the educational piece and, you know, honestly, how much are you getting bombarded on social media, by products? Every other second that you’re on social media, you’re getting advertisements. It’s actually really challenging to break through a lot of the noise and get to parents. So that’s why we really do believe very strongly in educating the care providers that parents are looking to for guidance. 

Heather: And, you know, the number one question, all the care providers want to know when someone says, Hey, I’m trying this new probiotic. They’re going to say, well, which one is it? And then the next question is, what are the side effects that are listed? So do you have any side effects that you’ve found from using Evivo? 

Dr. Tracy Shafizadeh: There have been no known side effects have been able to see or document both in our clinical trials and also in our at-home use of Evivo, which is wonderful. And the reason we believe that to be true is because we have not created something new that we are giving to baby. This is restoring a bacteria that has always been there and that we have actually eliminated, which is the side effects. The side effects come from when you eliminate the bacteria from baby’s gut, not when you put it back in. That being said, we go to great lengths to have the highest level of quality of manufacturing and packaging and shipment, because we don’t want to be careless about what we’re putting into baby. 

So we are extremely diligent on purity and accuracy of what’s in the product, what’s on the label and the quality of caring for that product all the way from manufacturing to putting into baby. And I would just say that maybe some of the anecdotal feedback, I wouldn’t say we have, like I said, no side effects, however, some moms say and dads say, I gave Evivo to my baby and they went several days without pooping and all of a sudden they had a blowout and it was the worst experience of any of our lives because it smells so bad. It went all the way up the neck, it’s all over the walls. You know, and we say that is exactly what we want to happen.

Let’s get all that pathogenic bacteria out of baby. Let’s get, let’s just clean the pipes, if you will. And let’s, then we can go to a few, soft, well-formed stools per day, rather than lots of loose watery stools per day. So that’s one feedback that we have to walk parents through a little bit is you might have an extravaganza of a blowout after you start Evivo. 

Heather: And you know, that can happen anyway. We call them Poopocalypses. 

Maureen: I was going to say, everyone’s going to have one of those, no matter what at some point. I remember my husband took my son to the YMCA when he was two. You know, he was like, I’m going to go to the gym, drop him off at the babysitter there. And she called him in the middle of his workout and she’s like, you have to come and help.

There was a poop incident. And my two year old had pooped so much that it was in his hair and his shoes. My husband picked him up fully clothed, put him in the shower in the locker room. And he was like, we’re just, this is a whole thing that needs to happen. It’s going to happen no matter what, everybody. So you may still practice once or twice. 

Heather: Oh, my Lord. Well, you know, let’s, let’s wrap up. We’ve given people so much to chew on, pun intended, but, you know, can you give us the three best things that our listeners can do to help their babies get? 

Dr. Tracy Shafizadeh: Absolutely. I would say, if I were starting over and I were having a baby today, I would say that getting mom and baby through labor and delivery, using whatever medical techniques and interventions are necessary to have healthy outcomes is the right thing to do. And if antibiotics or C-sections are involved, we now have a way to eliminate the unintended consequences of those interventions. So don’t fret, there is tremendous amount of hope.

If you can deliver your baby, however, gets the best outcome for mom and baby. And if you can breastfeed, if it’s possible for you and you provide B. infantis by giving your baby Evivo, I feel like those three things will set baby up on the best foot forward and the best trajectory early in life.

And then as baby continues to grow, if mom has mastitis and has to go on antibiotics again, you can always restart Evivo, that’s okay. So rather than looking at all of these different kind of disruptors of the gut microbiome as being really bad situations, I would say, just know that we are there for you.

We’ve done the work. We’ve done the science. We’ve published the data and we have a way to restore the infant gut microbiome when needed. So that would be my recommendation to mom. 

Heather: Thank you so much. I feel so much better about life in general and the trajectory of where we’re going with our microbiomes. And I just am so thankful for you all in the work that you’re doing. So thank you on behalf of all of our listeners for coming and spending time with us today and all up from here, right, Maureen? 

Maureen: Yeah. I’m very excited to dig into this product and, you know, think about how I can incorporate into my practice.

Dr. Tracy Shafizadeh: Great. Thank you so much. This was. So much fun and it feels so good to be speaking to two people who care so much. So thank you for the work that you do and your interest.

Heather:  Tell listeners where they can find you. 

Dr. Tracy Shafizadeh: Please come to Evivo.com, both for information about how and when to use Evivo with your baby, but also information on the clinical data that we have behind our product and how to talk to your healthcare provider about the infant gut microbiome, and whether Evivo is right for you.

Heather: Thank you. 

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Heather:  Well, that was just the most amazing interview and I am so excited about all of that information. 

Maureen: Me too. I’m so thankful for Bethany and Tracy for giving us their time to do that. I mean, they’re busy, they’re scientific researchers. They have a lot going on, you know, and they were like, sure, we’ll sit on the phone for two hours and talk about, you know, poop. Let’s do it. 

Heather: Right. I don’t think you listeners understand that this was not our first lengthy conversation with them. Like we have been really enjoying getting to know these fabulous researchers and we are so happy that we can share it with you all. And you know what else is really cool, all the research that they’re planning to do.

So there are just as excited about their future research as they are about the research they’re doing right now. So I am so happy that we get to be on board and watch how this evolves.

Maureen: We’re really punny today. 

Heather: I am the punniest I’ve ever been today. 

Maureen: I love it. Well, You know, I want to talk about like, what, what now? Right? We’ve given you all this information. We’re like, wow, this really blows. We’re missing this major bacteria that all infants need and nobody has it. And it sucks. Wait, here’s kind of a solution now, what do we do? So, you know, I don’t know. I don’t know what your next steps are out there because I don’t know your story.

I don’t know your life. I don’t know how old your baby is or what’s going on, but I do know what’s next for me. In a lot of our conversations today and before today, when we were chatting on the phone with our new friends and, and even like reading the website for Evivo, you know, the things that they, the symptoms they describe this bacterial supplement, this probiotic addressing are like, literally you can just describe my son’s first four months of life like that. 

Right. He cried a lot. He was what we would call colicky. Maybe if I had had a different doctor, they would have diagnosed him with reflux. Like who knows what that would have looked like if I had kind of your run of the mill pediatrician? But he, he was slow to gain weight.

He had a lot of weird poops all of the time. Every poop was weird, you know, and he was a difficult infant. And so when I reflect back on that, which I’ve been doing a lot now that I’m like, Oh, the impending date of having another baby is, like creeping, ever closer. I feel pretty excited to have this product at my disposal.

And I’m actually planning to give this to my new baby and kind of do a compare/ contrast. Like I know it’s a different human, but they’re going to ideally be born under similar circumstances. I’m going to have a vaginal birth at home. I’m going to breastfeed. So a lot of those kinds of things that I can control should be similar.

Heather: I’m excited too. We all get to benefit from your case study here? 

Maureen: Yeah, I like being a case study. 

Heather: Yeah. And as it turns out, several of our listeners do as well. And we have been kind of dripping the fact that we are going to be doing this interview over the past couple of weeks, and we’ve already had some interest.

And there’s been actually several people that have stepped up to say, I want to try this and I want to let you know what happens that we will have on the podcast at a future date to talk about the results and to really get in there and talk about the process, what it was like, and most of all, how their infants’ guts are doing.

Maureen: Yeah. And especially like, you know, is this really as easy to use as our you know, friends have said? Because while they’re researchers and they’ve done that aspect of it, they don’t have babies that they’ve actually used it on, you know. Or is it gonna work for me? Like it did in the research? I’m excited to find that out.

Heather: Yeah. And we will share all of that with you. Of course, we are an open book. 

Maureen: Yeah. So look forward to that. Probably I will be getting back to you about that in May or June.

Heather: May or June sounds good to me. Yeah. I mean, but I’m not pregnant. So you just tell me when. 

Maureen: We’ll see, it’s just we don’t, we don’t control any of this anymore, Heather. It’s just happening. Getting kicks in the spleen, you know, feeling like I’m going to pee my pants. My baby, like turns its head in my pelvis. 

Heather: You’re doing great. I’m proud of you. You just keep growing that human, girl. 

Maureen: Yeah. At least I don’t have to think about that. Yeah, it just happens. Yeah. Well, everybody, thank you for joining us on our gut microbiome journey, you know?

Heather: Yes. Don’t ever forget to trust your gut. 

Thanks for listening to The Milk Minute. If you haven’t already, please like, subscribe, and review our podcast wherever you listen. If you’d like to support our podcast, you can find us on Patreon at Patreon.com/MilkMinutePodcast  To send us feedback, personal stories, or just to chat, you can send us an email at MilkMinutePodcast@gmail.com 


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