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10 | Safety of Probiotics in Infants
Are probiotics safe to use in infants?
I'm so glad you're asking this question.
Before recommending any supplement, we should always be asking whether it's likely to be safe and effective.
This is even more important when using supplements with infants, where the stakes are higher than in many other life stages.
The short answer is that the safety profile of probiotics in infants is quite strong in many cases.
I don't recommend probiotics for all infants, but in some cases I believe that the benefits are likely to outweigh the risks.
These cases include preterm babies at risk of necrotizing enterocolitis, infants with colic, infants who are experiencing infrequent stools, and when antibiotics have been administered. There is some evidence suggesting that probiotic administration may be helpful in preventing atopic conditions (eczema/atopic dermatitis, asthma, etc).
Please remember that probiotic activity is species- and strain-specific. Review the studies relevant to your particular case, and be sure to select a high-quality brand from a trusted source.
Listen to the full episode above for more thoughts on this topic.
ReferencesAlFaleh, K., & Anabrees, J. (2014). Probiotics for prevention of necrotizing enterocolitis in preterm infants. The Cochrane Database of Systematic Reviews, 4, CD005496. https://doi.org/10.1002/14651858.CD005496.pub4
Guo, Q., Goldenberg, J. Z., Humphrey, C., El Dib, R., & Johnston, B. C. (2019). Probiotics for the prevention of pediatric antibiotic-associated diarrhea. The Cochrane Database of Systematic Reviews, 4, CD004827. https://doi.org/10.1002/14651858.CD004827.pub5
Karkhaneh, M., Fraser, L., Jou, H., & Vohra, S. (2020). Effectiveness of probiotics in infantile colic: A rapid review. Paediatrics & Child Health, 25(3), 149–159. https://doi.org/10.1093/pch/pxz007
Korpela, K., Salonen, A., Vepsäläinen, O., Suomalainen, M., Kolmeder, C., Varjosalo, M., Miettinen, S., Kukkonen, K., Savilahti, E., Kuitunen, M., & de Vos, W. M. (2018). Probiotic supplementation restores normal microbiota composition and function in antibiotic-treated and in caesarean-born infants. Microbiome, 6(1), 182. https://doi.org/10.1186/s40168-018-0567-4
Lerner, A., Shoenfeld, Y., & Matthias, T. (2019). Probiotics: If It Does Not Help It Does Not Do Any Harm. Really? Microorganisms, 7(4). https://doi.org/10.3390/microorganisms7040104
Ong, T. G., Gordon, M., Banks, S. S., Thomas, M. R., & Akobeng, A. K. (2019). Probiotics to prevent infantile colic. The Cochrane Database of Systematic Reviews, 3, CD012473. https://doi.org/10.1002/14651858.CD012473.pub2
Pärtty, A., Lehtonen, L., Kalliomäki, M., Salminen, S., & Isolauri, E. (2015). Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: A randomized, controlled trial. Pediatric Research, 78(4), 470–475. https://doi.org/10.1038/pr.2015.127
Quin, C., Estaki, M., Vollman, D. M., Barnett, J. A., Gill, S. K., & Gibson, D. L. (2018). Probiotic supplementation and associated infant gut microbiome and health: A cautionary retrospective clinical comparison. Scientific Reports, 8(1), 8283. https://doi.org/10.1038/s41598-018-26423-3
Sansotta, N., Peroni, D. G., Romano, S., Rugiano, A., Vuilleumier, P., Baviera, G., & Italian Society of Pediatric Allergy, Immunology (SIAIP), Microbiota Committee, Italy. (2019). The good bugs: The use of probiotics in pediatrics. Current Opinion in Pediatrics, 31(5), 661–669. https://doi.org/10.1097/MOP.0000000000000808
Smilowitz, J. T., Moya, J., Breck, M. A., Cook, C., Fineberg, A., Angkustsiri, K., & Underwood, M. A. (2017). Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: A phase I clinical trial. BMC Pediatrics, 17(1), 133. https://doi.org/10.1186/s12887-017-0886-9
Wickens, K., Barthow, C., Mitchell, E. A., Kang, J., van Zyl, N., Purdie, G., Stanley, T., Fitzharris, P., Murphy, R., & Crane, J. (2018). Effects of Lactobacillus rhamnosus HN001 in early life on the cumulative prevalence of allergic disease to 11 years. Pediatric Allergy and Immunology: Official Publication of the European Society of Pediatric Allergy and Immunology, 29(8), 808–814. https://doi.org/10.1111/pai.12982
Wong, C. B., Iwabuchi, N., & Xiao, J.-Z. (2019). Exploring the Science behind Bifidobacterium breve M-16V in Infant Health. Nutrients, 11(8). https://doi.org/10.3390/nu11081724
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Transcript
(00:03)
Hi, everybody, welcome to In the Clinic with Camille. My name is Camille Freeman. I am a registered herbalist and licensed nutritionist. And today I wanted to talk to you about infants and probiotics.
(00:15)
A few months ago, I was doing an observation session with a number of other practitioners and we were working with a mother and infant dyad where the baby was experiencing a fair amount of colic and distress, there was a lot of crying involved and so forth.
(00:32)
And the mother had already put the infant on probiotics. And we made a recommendation to switch to a what we perceived to be a slightly higher quality brand of probiotics in this case.
(00:43)
And one of the people observing expressed a little bit of concern about whether it was safe to use probiotics in infants. And so I wanted to share some of my reflections on this. I think it's always wise to be questioning the safety of any interventions, especially in infants and even more so in very young infants.
(01:05)
We know that when babies are born, those first few weeks and months, up to a year perhaps are really important for establishing healthy flora and that what happens in the in that critical time period does seem to affect that person for the rest of their life. So we know that there are some relationships between early flora and neuropsychiatric disease, immune function, respiratory disease, skin health and so forth. So all of these things are are extremely important.
(01:39)
And most babies develop their flora without any problem. We know that having a vaginal birth, breastfeeding, avoiding antibiotics and so forth are all helpful. But a lot of babies go on to develop perfectly healthy flora without some or all of those things as well.
(01:58)
So that's one thing that most babies, in my opinion, do not need probiotics. And I tend to avoid giving a baby, certainly newborns - anything up to six weeks - I usually do not recommend anything by mouth unless there are unusual circumstances and you use extreme caution, at least up through the age of about three months, that they seem to have a little bit more flexibility once you get to three months. And so those are some general guidelines.
(02:30)
But let me talk to you about when you may want to consider probiotics. There are is really good evidence supporting the use of probiotics for prevention of severe necrotizing enterocolitis in infants that are born preterm.
(02:47)
And that is well supported in the literature. Most physicians who are working with this population will recommend that that's not usually something that herbalists or nutritionists are going to be handling in an outpatient type of scenario.
(03:00)
But if not, you could certainly suggest that the physician or care team have a look at some of the evidence.
(03:06)
There was a really good Cochrane Review in 2014 on this topic suggesting that the probiotic supplementation in these infants helps to prevent harmful bacteria from crossing the mucosa.
(03:18)
It essentially drowns out potentially pathogenic microorganisms, and it seems to enhance the immune response of the infant.
(03:29)
So those are all great things.
(03:31)
When else might we consider using probiotics in infants one place? And this is what came into play in the case study I mentioned. One reason that we might consider it is in cases of infant colic, especially if some of the other care measures that usually help are not helping.
(03:51)
There is reasonable evidence about the use of probiotics in infant infantile colic that it does seem to help reduce the amount of time that infants spend crying in any given day. And if you've ever had an infant with colic, you'll know that even getting that down by 15 or 30 minutes can make a huge difference for the family unit.
(04:15)
So I do think that probiotics are worth a try when you have a dyad or a family unit that's in extreme distress, related to infantile colic and other things have been ruled out, such as any breastfeeding concerns and so forth, that it may make sense to consider probiotics in that case. Some of the most tested strains are the Lactobacilli reuteri DSM 17938, there's some reasonable evidence for that one in colic. There is a Cochrane review that came out in twenty nineteen that found that probiotics are probably better than placebo for preventing colic and decreasing daily crying time.
(05:00)
So all of this is helpful.
(05:03)
And there's a number of other studies looking at probiotic use in infants for a variety of things, including the prevention of allergies, eczema, neuropsychiatric concerns and so forth. Some of these follow the infants for up to one or two years. And there's a handful of studies looking at them up through 10 or even 12 years to look at potential long term effects.
(05:27)
Generally speaking, most of these studies find that there are few to no side effects or adverse effects noted in these infants.
(05:39)
Of course, we would want to use extreme caution and avoid these in infants who have very extreme immune compromise, that kind of thing, and of course, we would be working closely with a care team in that situation. But for the average generally healthy infant, it seems like probiotics have a reasonable safety profile.
(06:04)
One thing I do want to mention in this discussion is that probiotics is an extremely broad category. So when we just say taking probiotics, that's kind of like saying taking herbs, herbs are dangerous, herbs are not dangerous. Well, it depends on which herb we're talking about. Right?
(06:20)
Same is true with probiotics. There are different species and different strains of probiotics and each one has a unique profile, kind of like how each herb has a unique profile.
(06:30)
So when we're recommending probiotics to anyone, we want to be very specific about the strains that we're recommending and making sure that the strains we're recommending are matching up with the research suggesting that these are effective in this particular population. So the best studied strains in infants are Lactobacillus reuteri, DSM 17938, which already mentioned as being particularly studied for colic in infants. There's also bifida, several species of bifida bacteria, including breve M-16V and longus, the infantalis species, EVC 001.
(07:08)
And there are also several studies looking at the Lactobacillus rhamnosus, either the GG or the HN001, all in infant populations. So I feel really good about those that we do have at least a reasonable idea that they are safe and effective in this particular population, we always want to be asking, though, could there be harm any time we we see something where it has the potential to make dramatic changes, especially in the long term, especially in the immune function, we also want to be asking, well, can it have adverse effects in the long term? It doesn't seem to have adverse effects in the short term, not noticing any difference between adverse events and placebo versus probiotic and that kind of thing in essentially any of the studies that have been done.
(07:57)
But what about the long term?
(08:00)
There is one study that does raise a little bit of concern, and I want to talk to you about it here. This is a study it's an observational study by Quin and colleagues in 2018, and I'll put a link to it in the show notes if you'd like to check it out. It's an open access text so you can see the whole thing for yourself. But they were actually doing a study on fish oil in pregnancy and in infancy. And they found in this study that 40 percent of the people in their study were taking probiotics, just self-prescribed on their own.
(08:32)
And they thought, oh, that's interesting. I wonder if there's any changes associated with this.
(08:37)
So they looked at these for the 40 percent of people and this was about thirty five people, so this is not a huge study here. They're looking at these 35 mother child dyads who had self administered probiotics either to the pregnant person or they were giving them to the infant after the birth had happened.
(08:59)
And they found that essentially there was really no change in a lot of the microbial markers, including short chain fatty acids composition and that kind of thing.
(09:08)
There was a higher fecal secretary IgA response in the infants who had gotten probiotic supplementation, but there was really no long term changes, except they noted that the parents reported a higher incidence of what they call mucosal-associated illness once those infants became toddlers. And so they said, well, this is potentially concerning.
(09:34)
We should look at this. Maybe we shouldn't be using probiotics, etcera, etc..
(09:39)
I look at this data and I think, OK, yes, that is interesting, but. Who is giving them a probiotic, their infants, probiotics? There's a certain type of person who may do this. This may be people who suspect that there's a reason to do this for for example, they have a family history of eczema or allergies or something like this. It may be people who are overly protective for some reason. So this study, because there is not randomization, because there was not a true control group in that sense, it's really hard to tell if the probiotics specifically are causing this reaction at about one to two years.
(10:20)
So is it worth keeping an eye on? Yes. Does it outweigh the numerous studies suggesting benefit in certain populations? Maybe, maybe not.
(10:31)
I don't think, like I said, I don't think it makes sense to give all babies probiotics just because, however, if there is a specific situation going on, such as the colic in the case I mentioned, or, you know, there's a strong desire to prevent allergies and eczema because of what happened with a previous child or a strong family history or something like that, is it worth considering? Yes, I would carefully look at which strains are being used and I would also very carefully look at dosing strategies.
(11:07)
I would try it for a while, back off, see if there is an association with symptoms when you're using the probiotics versus when you're not at it back in, kind of do the addition withdrawal once or twice. And that may really help. We know, for example, in colic that a lot of babies will get over that themselves in a few weeks and it's hard to make any clear associations with any kind of interventions that you're doing. So it's worth it's worth experimenting.
(11:36)
And I don't recommend that babies stay on it forever.
(11:39)
However, I've just seen so many infants where there is pretty clear benefit that goes away when they're withdrawn and comes back when they're added. This includes colic and also babies who are having trouble with constipation, where the parents are finding that the infant is experiencing discomfort and they're needing to use rectal manual stimulation to get the baby to defecate. That stooling is not happening regularly. And the baby seems to be relieved or feeling better when it does happen that probiotics can really help in those situations.
(12:14)
So I encourage you to take it on a case by case basis, keep your eyes open to the literature as it becomes available to see, you know, if in any other studies come around that suggests a possible reason for caution or holding back. Absolutely. Take them into account and make your own decisions about what seems safe to you. But in my opinion, there are times where it seems like the benefits outweigh the risks in recommending probiotics to infants, especially once they reach the age of about three months or so.
(12:51)
It seems like a reasonable choice for some babies. So I hope that's helpful in your decision making.
(12:56)
I'm sorry that I can't give you a clear absolutely or for sure not answer, but I will post a lot of the studies, some of the studies that you may want to have a look at on my website.
(13:07)
And I'd love to hear your thoughts as well. All right. I hope that was helpful. And we'll talk soon.
Hi, everybody, welcome to In the Clinic with Camille. My name is Camille Freeman. I am a registered herbalist and licensed nutritionist. And today I wanted to talk to you about infants and probiotics.
(00:15)
A few months ago, I was doing an observation session with a number of other practitioners and we were working with a mother and infant dyad where the baby was experiencing a fair amount of colic and distress, there was a lot of crying involved and so forth.
(00:32)
And the mother had already put the infant on probiotics. And we made a recommendation to switch to a what we perceived to be a slightly higher quality brand of probiotics in this case.
(00:43)
And one of the people observing expressed a little bit of concern about whether it was safe to use probiotics in infants. And so I wanted to share some of my reflections on this. I think it's always wise to be questioning the safety of any interventions, especially in infants and even more so in very young infants.
(01:05)
We know that when babies are born, those first few weeks and months, up to a year perhaps are really important for establishing healthy flora and that what happens in the in that critical time period does seem to affect that person for the rest of their life. So we know that there are some relationships between early flora and neuropsychiatric disease, immune function, respiratory disease, skin health and so forth. So all of these things are are extremely important.
(01:39)
And most babies develop their flora without any problem. We know that having a vaginal birth, breastfeeding, avoiding antibiotics and so forth are all helpful. But a lot of babies go on to develop perfectly healthy flora without some or all of those things as well.
(01:58)
So that's one thing that most babies, in my opinion, do not need probiotics. And I tend to avoid giving a baby, certainly newborns - anything up to six weeks - I usually do not recommend anything by mouth unless there are unusual circumstances and you use extreme caution, at least up through the age of about three months, that they seem to have a little bit more flexibility once you get to three months. And so those are some general guidelines.
(02:30)
But let me talk to you about when you may want to consider probiotics. There are is really good evidence supporting the use of probiotics for prevention of severe necrotizing enterocolitis in infants that are born preterm.
(02:47)
And that is well supported in the literature. Most physicians who are working with this population will recommend that that's not usually something that herbalists or nutritionists are going to be handling in an outpatient type of scenario.
(03:00)
But if not, you could certainly suggest that the physician or care team have a look at some of the evidence.
(03:06)
There was a really good Cochrane Review in 2014 on this topic suggesting that the probiotic supplementation in these infants helps to prevent harmful bacteria from crossing the mucosa.
(03:18)
It essentially drowns out potentially pathogenic microorganisms, and it seems to enhance the immune response of the infant.
(03:29)
So those are all great things.
(03:31)
When else might we consider using probiotics in infants one place? And this is what came into play in the case study I mentioned. One reason that we might consider it is in cases of infant colic, especially if some of the other care measures that usually help are not helping.
(03:51)
There is reasonable evidence about the use of probiotics in infant infantile colic that it does seem to help reduce the amount of time that infants spend crying in any given day. And if you've ever had an infant with colic, you'll know that even getting that down by 15 or 30 minutes can make a huge difference for the family unit.
(04:15)
So I do think that probiotics are worth a try when you have a dyad or a family unit that's in extreme distress, related to infantile colic and other things have been ruled out, such as any breastfeeding concerns and so forth, that it may make sense to consider probiotics in that case. Some of the most tested strains are the Lactobacilli reuteri DSM 17938, there's some reasonable evidence for that one in colic. There is a Cochrane review that came out in twenty nineteen that found that probiotics are probably better than placebo for preventing colic and decreasing daily crying time.
(05:00)
So all of this is helpful.
(05:03)
And there's a number of other studies looking at probiotic use in infants for a variety of things, including the prevention of allergies, eczema, neuropsychiatric concerns and so forth. Some of these follow the infants for up to one or two years. And there's a handful of studies looking at them up through 10 or even 12 years to look at potential long term effects.
(05:27)
Generally speaking, most of these studies find that there are few to no side effects or adverse effects noted in these infants.
(05:39)
Of course, we would want to use extreme caution and avoid these in infants who have very extreme immune compromise, that kind of thing, and of course, we would be working closely with a care team in that situation. But for the average generally healthy infant, it seems like probiotics have a reasonable safety profile.
(06:04)
One thing I do want to mention in this discussion is that probiotics is an extremely broad category. So when we just say taking probiotics, that's kind of like saying taking herbs, herbs are dangerous, herbs are not dangerous. Well, it depends on which herb we're talking about. Right?
(06:20)
Same is true with probiotics. There are different species and different strains of probiotics and each one has a unique profile, kind of like how each herb has a unique profile.
(06:30)
So when we're recommending probiotics to anyone, we want to be very specific about the strains that we're recommending and making sure that the strains we're recommending are matching up with the research suggesting that these are effective in this particular population. So the best studied strains in infants are Lactobacillus reuteri, DSM 17938, which already mentioned as being particularly studied for colic in infants. There's also bifida, several species of bifida bacteria, including breve M-16V and longus, the infantalis species, EVC 001.
(07:08)
And there are also several studies looking at the Lactobacillus rhamnosus, either the GG or the HN001, all in infant populations. So I feel really good about those that we do have at least a reasonable idea that they are safe and effective in this particular population, we always want to be asking, though, could there be harm any time we we see something where it has the potential to make dramatic changes, especially in the long term, especially in the immune function, we also want to be asking, well, can it have adverse effects in the long term? It doesn't seem to have adverse effects in the short term, not noticing any difference between adverse events and placebo versus probiotic and that kind of thing in essentially any of the studies that have been done.
(07:57)
But what about the long term?
(08:00)
There is one study that does raise a little bit of concern, and I want to talk to you about it here. This is a study it's an observational study by Quin and colleagues in 2018, and I'll put a link to it in the show notes if you'd like to check it out. It's an open access text so you can see the whole thing for yourself. But they were actually doing a study on fish oil in pregnancy and in infancy. And they found in this study that 40 percent of the people in their study were taking probiotics, just self-prescribed on their own.
(08:32)
And they thought, oh, that's interesting. I wonder if there's any changes associated with this.
(08:37)
So they looked at these for the 40 percent of people and this was about thirty five people, so this is not a huge study here. They're looking at these 35 mother child dyads who had self administered probiotics either to the pregnant person or they were giving them to the infant after the birth had happened.
(08:59)
And they found that essentially there was really no change in a lot of the microbial markers, including short chain fatty acids composition and that kind of thing.
(09:08)
There was a higher fecal secretary IgA response in the infants who had gotten probiotic supplementation, but there was really no long term changes, except they noted that the parents reported a higher incidence of what they call mucosal-associated illness once those infants became toddlers. And so they said, well, this is potentially concerning.
(09:34)
We should look at this. Maybe we shouldn't be using probiotics, etcera, etc..
(09:39)
I look at this data and I think, OK, yes, that is interesting, but. Who is giving them a probiotic, their infants, probiotics? There's a certain type of person who may do this. This may be people who suspect that there's a reason to do this for for example, they have a family history of eczema or allergies or something like this. It may be people who are overly protective for some reason. So this study, because there is not randomization, because there was not a true control group in that sense, it's really hard to tell if the probiotics specifically are causing this reaction at about one to two years.
(10:20)
So is it worth keeping an eye on? Yes. Does it outweigh the numerous studies suggesting benefit in certain populations? Maybe, maybe not.
(10:31)
I don't think, like I said, I don't think it makes sense to give all babies probiotics just because, however, if there is a specific situation going on, such as the colic in the case I mentioned, or, you know, there's a strong desire to prevent allergies and eczema because of what happened with a previous child or a strong family history or something like that, is it worth considering? Yes, I would carefully look at which strains are being used and I would also very carefully look at dosing strategies.
(11:07)
I would try it for a while, back off, see if there is an association with symptoms when you're using the probiotics versus when you're not at it back in, kind of do the addition withdrawal once or twice. And that may really help. We know, for example, in colic that a lot of babies will get over that themselves in a few weeks and it's hard to make any clear associations with any kind of interventions that you're doing. So it's worth it's worth experimenting.
(11:36)
And I don't recommend that babies stay on it forever.
(11:39)
However, I've just seen so many infants where there is pretty clear benefit that goes away when they're withdrawn and comes back when they're added. This includes colic and also babies who are having trouble with constipation, where the parents are finding that the infant is experiencing discomfort and they're needing to use rectal manual stimulation to get the baby to defecate. That stooling is not happening regularly. And the baby seems to be relieved or feeling better when it does happen that probiotics can really help in those situations.
(12:14)
So I encourage you to take it on a case by case basis, keep your eyes open to the literature as it becomes available to see, you know, if in any other studies come around that suggests a possible reason for caution or holding back. Absolutely. Take them into account and make your own decisions about what seems safe to you. But in my opinion, there are times where it seems like the benefits outweigh the risks in recommending probiotics to infants, especially once they reach the age of about three months or so.
(12:51)
It seems like a reasonable choice for some babies. So I hope that's helpful in your decision making.
(12:56)
I'm sorry that I can't give you a clear absolutely or for sure not answer, but I will post a lot of the studies, some of the studies that you may want to have a look at on my website.
(13:07)
And I'd love to hear your thoughts as well. All right. I hope that was helpful. And we'll talk soon.
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