Everything You Need to Know About Probiotics, Part 3

A New and Comprehensive Guide to Probiotics

Imbalances of the gut microbiota are becoming increasingly common and can cause distressing digestive symptoms and an array of seemingly unrelated symptoms and conditions. These include mood, energy, skin, joint health, metabolism, sleep, immune function, hormone balance and thyroid health. Thankfully, probiotics can help to correct these imbalances and relieve symptoms. Hundreds of research studies provide evidence for these benefits.

I’ve recently published a comprehensive, 43-page guide to getting the most out of your probiotic supplements on my website. I’ve also developed this podcast series to highlight some of the key takeaways that you need to know about probiotic therapy. This episode is part 3 in a 3-part podcast series.

When used correctly, probiotics are a powerful therapy with a surprisingly long list of health benefits. But for many health care consumers, the results of probiotic therapy can be suboptimal due to lack of information or poor probiotic quality.

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Episode Summary

Dr. Michael Ruscio:     Hi everyone. In today’s episode, we discuss part three of our three-part summary of the comprehensive probiotic article that we recently released. We touched on the specifics for how to use the 3 for BALANCE Probiotic Protocol, which is essentially using three different probiotic formulas together. Namely, our Lacto-Bifido blend probiotic, our Saccharomyces boulardii probiotic, and our soil-based probiotic and how important that can be in leading to balance the microbiota. We lay out the evidence showing that probiotics are not condition-specific as another very important point. We speak to some of the criticisms that we need more research for probiotics and we actually have a really good infographic that dismantles the argument that we need better evidence. We also discuss quality assurance measures, and this may account for why some people do not see adequate results from probiotics.

Now it’s not to say that probiotic quality assurance is the end-all, be-all. Supplement companies definitely use that as a way to rip you off and sell you things that are more expensive than they should be. But, and as you’ll see, we support with a number of references in the article, roughly 50% of probiotics don’t meet their label claims. This could be why the response patients report from probiotics with their own tinkering compared to what I see when they come into the clinic or compared to what readers of Healthy Gut, Healthy You report, is vastly different. It’s no surprise that if 50% of probiotics don’t meet their label claim, meaning they don’t have as much in them as they say or they don’t even have the actual bacteria that they claim, that results could be less than what one might expect.  When you get a good probiotic, you will likely see a pretty notable difference in your results.

We also talk about the safety of probiotics for infants and the different dose ranges used and give you some troubleshooting for how to go on the protocol irrespective of if you’re a sensitive patient or a non-sensitive patient. Also some tips for how to find your ideal maintenance dose. That’s a number of things that we touch on. Again, if you haven’t tried our 3 for BALANCE protocol, I would really encourage you to do so. I hate recommending things that I’ve put together because I don’t want to sound self-promotional, but at the same time, the number of cases that have come in where they’ve seen other doctors or tried other do-it-yourself protocols, and we just simply put them on this  3 for BALANCE protocol and all their symptoms go away, it’s fairly high.

If I can save you from spending money on seeing a functional medicine doctor or a naturopath and allow you to get there with some of your own self-experimentation, that’s a huge win for me. So our Lacto-Bifido blend probiotic, our Saccharomyces boulardii probiotic and our soil-based probiotic can be used together in a comprehensive support protocol. That can allow you to run a good thorough probiotic protocol and then know what your response from probiotics will be and get off the merry-go-round of trying this, that, and the other probiotic formula that are spun with different marketing claims. It really simplifies the landscape. With that, we’ll jump into the body of the episode here and I hope you enjoy it.

Episode Intro

DrMR: Hi, everyone. Welcome back to Dr. Ruscio Radio. This is Dr. Ruscio and today we will launch into part three of our three-part series on Everything You Need to Know About Probiotics. We are picking up where we left off with the 3 for BALANCE Probiotic Protocol. This is my attempt at a pithy name for how impactful and important it is to use a three-formula probiotic protocol.  This can be the difference for some people between really robust improvements compared to minimal or no improvements at all. Before we launch into some of the details of implementation and rationalization, I want to lead with a few quotes.

Simplicity

One of the things that I’ve noticed is sometimes, and I think rightfully so, people who aren’t feeling well, especially if they haven’t been feeling well for a while, expect it to be difficult to heal.  They expect it to be expensive, time-intensive, cerebral or requiring lots of testing. In my experience and myself as a patient, when you find a good provider, they actually make the process much easier and more simple. What I’ve noticed is sometimes patients have a hard time conceiving that what they need to do in order to improve is as easy as I lay it out to be. I want to hit that head-on here and really, address the fact that even though it sounds simple in practice to take three probiotics together, the 3 for BALANCE protocol.  That simplicity is a derivative of quite a bit of time, research, experimentation, years and years of IBS and probiotic research unfolding and producing findings for us to pull from. Maybe we could say it this way, if you watch an expert, a professional soccer player, they make things look easy even though getting to that point where it looks easy took a tremendous amount of training and work.  So I want to share a few quotes.  Isaac Newton, “Truth is found in simplicity, not in the multiplicity and confusion of things.” L. Ron Hubbard, “The evolution of knowledge is toward simplicity, not complexity.” Martin Fischer, “Knowledge is a process of piling up facts. Wisdom lies in their simplification.” Lance Wallnau, “Complexity is impressive, but simplicity is genius.”

Again, I share these to impress upon you the fact that you will be contending with complicated theories out there on the internet and the complicated theories in my experience oftentimes do not work any better, in fact, work not as well as the well-vetted simple protocols. This is your simple protocol.

Starting the Protocol

What do you do? Two approaches for starting the 3 for BALANCE Probiotic Protocol. If you are a non-sensitive patient, meaning you don’t typically have negative reactions to supplements, start with all three together at the same time. That would be our Lacto-Bifido blend probiotic, our Saccharomyces boulardii probiotic and our soil-based probiotic, so with all three together.

Now if you are sensitive, start with one at a time. Give yourself a short period to assess if you’re having a reaction. Usually, three to seven days allows time to determine if they’re having a reaction or not. There’s another piece there. There can be a little bit of initial turbulence when starting on a probiotic, stomach grumbling, loose bowels, maybe a bit of constipation, maybe a bit of bloating. If this is an adjustment reaction, it will usually only last for a handful of days. By the time you’re getting to about the week mark, this has resolved or it’s clearly abating.  If you’re getting toward the week mark and these negative symptoms, whatever they are, are still persisting and are not getting any better, then that tells you you’re having a negative reaction to that type of probiotic. Put that one aside and move on to the second, repeat and move on into the third. Maintain in the protocol the probiotics that you tolerate. Again, people often ask me, “What symptoms should I be looking for?” Because the gut affects so many different systems and symptoms, we can’t say there are one or two different symptomatic reactions to be looking for. There could also be skin reactions, joint reactions, fatigue, insomnia. There could be any negative manifestation if someone’s having a reaction.

The key question is, “Did this symptom appear shortly after starting the probiotics?” and if so, that makes it very likely that it was probiotics that were causing that. Now again, side effects from probiotics, despite what you hear on the internet are actually quite rare and the IBS research clearly shows this. It’s not to say that some won’t react, but placebo and nocebo are powerful. If the SIBO community has inculcated you into thinking you’re going to have a negative reaction, there is about a 45% chance that you will psychosomatically manifest a negative reaction. Approach this with a clean expectational slate, reactions are rare.  In the clinic, we do see very sensitive patients and some will have reactions, but it’s pretty darn rare. Even the most sensitive patients can usually tolerate at least one probiotic formula if not two. Keep that in mind. If you’re sensitive, start one at a time. Determine what ones you tolerate and the ones that you don’t tolerate leave aside. Also, don’t worry about it. If you don’t tolerate a category, don’t think you need to force it in your system, okay? Two starting points, non-sensitive all three at once, sensitive start one at a time until you determine the ones that you tolerate and then continue with those.

Once you’ve gotten to the point where you’re on your probiotics, whether it’ll be all three or two or in a rare, rare instance only one, give yourself about three to four weeks on the full protocol that you’ve been able to work yourself up to. After three to four weeks, you should be able to have a gauge of, “Yes, I’m improving,” not “I’m totally fixed, but yes, I’m improving,” or “No, I’m noticing nothing at all.” Again, it’s rare that someone will notice no improvement at all, but just trying to help you see the bigger picture here. Most likely what will happen is you will be experiencing some degree of improvement.  It might be 30%, it might be 90% but what you’re looking for at that first three-to-four-week reevaluation period is, “Yes,” or, “No, I’m improving.” Again, it’s not, “Everything is cured or resolved,” but, “Are things trending in the right direction?” If so, then continue until you notice you hit a plateau.

That plateau may come a month later, so you reevaluate it at one month in and then you plateaued at two months in or the plateau may occur three to four months later. This is important to keep in mind, especially when understanding that there does seem to be this law of diminishing returns with any type of treatment, meaning you see lots of improvements fairly quickly in the initial phases and then the closer you get to your goal, 100%, the slower the rate of improvement tends to be.

What this causes some patients to do is to doubt if they’re doing the right thing. Just understand that to see, let’s say within the first month, a 60% improvement in how you’re feeling and then over the next month you feel like you only gain an additional 15% in how you’re feeling, that’s not abnormal. The closer you get to 100%, the slower the gains tend to be. I share that just so you don’t prematurely jump course to something else. Slow and steady improvement I will take any day over swinging wildly for the fences of some home run improvement. Start on the protocol. Reevaluate three to four weeks in. At that point, you’re either saying, “Yes, I’m noticing the effect,” or “No, I’m not noticing any effect.” If you are noticing that effect, maintain the course until you plateau.

Plateaus and Dosing

Once you’ve plateaued, maintain what you’re doing I would recommend at least one to two months, so you can establish consistency in your new peak level of improvement. Then when you feel ready, attempt to wean yourself down to the minimal effective dose.  Now if you’ve noticed nothing at all in terms of improvement, I would refer you to Healthy Gut, Healthy You so you can get a more comprehensive all-encompassing protocol for how to layer in other therapies. This podcast is not about the full comprehensive gut healing algorithm. It’s about the probiotic piece. I’ll just pin that on the board to go to Healthy Gut, Healthy You if you’re on the probiotic protocol and not noticing any improvement.

Now regarding dosing, the dosing here looks like either one-fourth of a teaspoon of our Lacto-Bifido blend probiotic or four pills one to two times per day. By the way, in the article, there’s a dosing table with all this listed out for you. For the Saccharomyces boulardii, two to four pills, one to two times per day. For the soil-based probiotic, one to two pills, one to two times per day. With or without food, it doesn’t really matter. If it’s easier for you to take these things with all your other supplements if you’re taking other things in the morning with breakfast and then again in the afternoon at lunch, do that. If you get up and you have a glass of water after you brush your teeth, let’s say, and you do that in the morning and then you do another dose before you go to bed, that’s fine. 

If you’re going to be inconsistent with your dosing because you’re trying to be perfect and take some of these probiotics with food and some without, it’s not worth it. I would simply recommend you dose the probiotics however it works best for you. Take them one to two times per day. If it’s easy for you to take them with food, do that. If it’s easier to take them on an empty stomach, do that. Do not make your life harder than it has to be striving for this “perfect dosing protocol” because there is no research from what I’ve seen suggesting one-dosing protocol works any better than the other. In fact, as we’ll cover in a moment here, the dose range used also varies widely.

This is why you see a dose range of two to four pills one to two times per day with the Saccharomyces boulardii as an example. Sometimes patients say, “Well, what exact dose should I take?” It depends on how you look at this. That could be frustrating,  or you can understand that this is empowering precisely because there IS no perfect dose.  The research studies have used a wide range of dosages and all have shown benefits. I have the luxury of being able to take one dose per day and hit the lower end of the dose range or if I’m an overachiever, I want to put additional funds into this, I want to be more aggressive, I can take the two doses per day. Either path seems to be okay.  Depending on how we frame this, having a range and flexibility can either stress someone out which you should not or be looked at as an empowering bit of flexibility that can enable the probiotic protocol to be personalized to the individual, whether that be from a cost perspective or a compliance perspective.

Condition Specific Dosing

We made a chart in the probiotic article here and I’m not going to go through every point, but I’ll go through a number of them. For IBS, irritable bowel syndrome, a range between 10 million CFU per day to 1,000 billion CFU per day has been used. For SIBO, a range between 100 million to 10 billion CFU has been used per day, wide ranges. Leaky gut, anywhere from 10 to 100 billion per day.  Fungus, limited research show about 5 billion is all that has been used. Not to say that’s the only dose for fungus, but there are limited studies. When we look at a model with more studies, H. pylori as an example, a dosage range of 20 million to 1,800 billion has been used per day. We try to find the easiest way to list out some of these numbers, so pardon the semi-unconventional way we’ve listed these. They make more sense when you read them in the article. For infection of various sorts, 10 to 15 billion CFU per day. Looking at mood and depression, 10 million to 100 billion. Brain fog, 1 billion to 1,000 billion. Again, pardon the funky numbers there, they look better in the article when you read them. They sound weird admittedly.  For sleep, one to 100 billion. Autoimmunity, 100 million to 10 billion. Thyroid function, 1 billion to 100 billion CFU per day. When you look at this, it’s very difficult to say this is the ideal or perfect range which is actually, again if we frame it the right way, a good and empowering bit of information. We have dose ranges and that’s good for you, the consumer because it means you don’t need to be pigeonholed into a highly specific dose. Again, we touched on probiotics with or without food. There’s another section about that in the article that just elaborates a bit.

Now, what about the rationale? We already touched on this but I want to circle back to that stool analogy that we used earlier. We need to understand that these probiotics are similar but also uniquely different.  Category one is the Lacto-Bifido probiotic blend (or lactic acid-forming bacteria), category two is actually not a bacteria, it’s a fungus, Saccharomyces boulardii and category three is the soil-based, non-lactic acid-forming and spore-forming bacteria. As the analogy would state, they may occupy different niches of the gut and/or support the gut in subtly different ways.

What this may look like is a stool on which you would sit with one leg.  A one probiotic protocol would be akin to a one-legged stool.  It’s conducive to supporting balance, but it’s wobbly. A three-legged stool or a three probiotic formula protocol gives you three legs of supporting balance in your gut ecosystem and is more conducive to balance, healing, and repair.

This is the  3 for BALANCE Probiotic Protocol. The reason why it’s so effective is that it’s more comprehensive support. Here’s another analogy I used during an interview with Melissa Hartwig about a week ago. Let’s say you have weak hamstrings, and because you have weak hamstrings, you have some knee pain and you have some back pain and you’re doing some research and you find, “Man, there’s a selection of different hamstring strengthening exercises.”

Some you bend forward and you extend your back. This would be, I believe, if I’m remembering correctly here, a closed chain version of a hamstring exercise. Whereas if you did something like a hamstring curl where your feet move and you’re pushing against a surface that moves, that would be an open-chain exercise. It would make sense that if you wanted to have the most comprehensive hamstring rehabilitation protocol, you would use more than one hamstring exercise.  The parallel here is that for a probiotic protocol it makes more sense to have a comprehensive multi-formula probiotic protocol to achieve the balance that you’re looking for in your gut.

The same thing, you want to have strong hamstrings, you want to work them from multiple angles. You want to have a strong gut, you want to support your microbiota through multiple probiotics.

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Now to the question, “But it’s easier if I use just one probiotic.” Sure. I agree. It’s also easier if you do just one day a week at the gym or just one hamstring exercise or you eat just one food. Obviously, that’s not the most conducive to balance and to health. Think about it this way. If you use the  3 for BALANCE protocol, you reduce the probability that you will have to stay on the probiotic merry-go-around, trying one formula, a month or two later reading another blog or listening to a podcast about another new novel and exciting formula and then trying that one.  Then months later trying a different one and round and round and round you go. Trying category one and category two and category two and category three and category one, not understanding our guiding principles of the categorization of the formulas and then using them all at once and going on the comprehensive protocol and then being able to say, “This is the effect I will realize from probiotics. It’s either enough to get me there or I’ve got to go further”, and that’s when you go to Healthy Gut, Healthy You for that further, but now you can close the book on your trialing of probiotics really once and for all. That’s really the goal of this.

Real Results

Now, we mentioned Phyllis either in podcast one or two of this three-part series. In the article, I linked to Phyllis’s case study.  Essentially Phyllis had experienced digestive issues for three years, was previously diagnosed with SIBO, did the paleo low FODMAP diet for two years, had tried random probiotics prior and had negative reactions and nothing was working. After roughly one month on the 3 for BALANCE Probiotic Protocol, she experienced increased energy, improved motility or bowel regularity and improved overall gut health as she described it.

The key takeaway here is that, yes, there are people out there who are doing the diet piece pretty darn good (paleo low FODMAP), who are experimenting with probiotics and in this case even having negative reactions.  She just needed a good thorough protocol to get her over the hump. We didn’t need to do a SIBO breath test,  or stool test, or antimicrobial, or elemental dieting, or immunoglobulin therapy. Now, there are cases that we’ll need these things, yes, but you don’t want to overlook or incorrectly execute a foundational step which is probiotic, which is why this is so important.

In the next part of the article, we just reiterate how to tell if a probiotic is working and give you a bullet list. We already hit on this, so I’ll gloss over that for now, but essentially, it’s reiterated for you in a series of bullet points. There are also a few guidelines for what finding your minimal effective dose will look like.  I believe we touched on this in one of the last podcasts, but just remember that finding the minimal effective dose oftentimes involves you going to an ineffective dose, and seeing a regression of how you’re feeling or a resurgence of your symptoms. Be attentive to that. There’s a line and if you are on the line, you will have no symptoms and will be at the minimal effective dose. If you go underneath that line, you’ll have some symptoms coming back because you’re at an ineffective dose. Part of figuring this out is not just weaning down to zero or cutting your dose in half, it’s incrementally decreasing your dose and then noting your symptoms. The fact that these things don’t often come back quickly can throw people.

We released a case study recently with Mason who had chronic acid reflux and he saw dramatic improvements from the 3 for BALANCE Probiotic Protocol and was very, very happy with how he was doing. We followed up two months later after I advised him to do some tinkering to find his minimal effective dose. When we followed up, he said, “Yeah, doc, I’m still doing great. I was at 100% last time we spoke. Now, I’m about 90%.” I said, “Okay,” and I said, “With the probiotics, what are you doing there?” He said, “Well, I came off them completely.” I said, “Does this correlate with you seeing that 10% regression?” He said, “Oh yeah, it did.”

In his case he, he just overlooked the fact that when he came off completely, he saw a 10% regression in his symptoms, and for whatever reason, he didn’t tie together that there was a correlation between coming off the probiotics and that 10% regression, probably because it was subtle. It didn’t happen in the course of a day. It happened over the course of two months. Sometimes when these things are gradual, they can sneak up on us. Keep your eyes out for that. On the other side of the coin here, don’t expect that you’ll need to be on probiotics forever because I want to be careful not to paint that scenario as the expectation either.

For me, I do notice I feel better when I take at least one dose of all three and our Gut Rebuild Nutrients every morning. I wouldn’t say that I need it, but as you probably heard me say before, I feel more impervious to a bad nights sleep, alcohol, bad food, travel. Those things used to bug me, especially over the past few months where I’ve been doing more traveling.

I used to notice a bit of bloating when I would travel and I’m assuming it’s from the time zone shifting and from the altitude and everything else. I have had none of that which has been really nice. I wouldn’t say I “medically need” a probiotic, but I certainly go from average to optimal when I’m using them. 

That’s my experience, that’s not necessarily going to be your experience but just approach the weaning objectively. You may feel better on one dose of all three on every day or most days or you may not need them at all. You may be someone, let’s say your situation is somewhat severe and you’re early in your healing phase, you may notice the full dose is what’s needed to keep you from regressing. Make sure over time to reassess your minimal effective dose because where you are three months in may be different than where you are a year and three months in.

Regression

Also, remember there’s a section here called, “I was doing great on my maintenance dose until …” Life happens.   You may go on vacation or travel or have a stressful period and notice that you regress. If you’re on a low minimal effective dose and then life got in the way and you regressed, you can go back to the fuller dose for a term and then once you’re feeling well go back to your slightly lower dose. I hope I’m not giving you too much information here, but I’m trying to arm you with these simple things because we had a discussion, I forget who this was with now, but one of our patients at the clinic who felt so empowered by this knowledge.   That when she had a regression in how she was feeling, she learned that she didn’t need to go to a doctor’s office and do a bunch of testing because she had discovered, I actually believe this was a Healthy Gut, Healthy You reader, through the book protocol what worked for her.  She could just revisit what worked for her prior when she was having a little bit of her regression and she felt fine. So I share this to empower you. I know it’s simpler if I just say, “Hey, do this one thing and everything will be great,” but that’s not how these things work in the real world. I’d rather give you a bit of nuance and empower you than try to give you the dumbed-down version and disempower you. Again, if the probiotic protocol was very helpful if down the road something pops up and you regress, you can revisit that and oftentimes that can quell the flare and reduces your need for utilization of the healthcare system.

Now again, I want to be careful to say if you’re being monitored by a doctor, do your followups, don’t disregard the system, but this can be used to empower you so that you have a minimal need to seek out care if you’re not being advised on a followup for whatever reason.

Not Condition Specific

The next section here really needs to be drilled home. Probiotics are not condition specific. You’ve probably heard my spiel on this before, but I just to package it all together here and tie it up in a bow with references.  Now, you’ll sometimes hear, “Only X probiotic has been proven effective for Y symptom,” and this sounds appealing.  To me, someone who is critical and evidence-based, this type of thinking appeals to me, but just because it sounds cautious and scientific doesn’t mean it’s actually correct and what the evidence in the science actually supports. I do think this is done by providers who are well-intentioned, but it doesn’t change the fact that it’s wrong.

Here is the proof.  There are six bullets here with maybe about 24 to 36 references, that support all these claims. Bullet one, multiple studies have found probiotics can improve mood.  Most of the probiotics were different iterations of category one, but there were different formulas used in each one of, in this case, three different studies.

Bullet two, different categories of probiotics have been shown to improve IBS including different probiotic formulas from category one, category two and category three. To say there’s a magic probiotic protocol for IBS would be totally in violation of what science says. What about constipation? We need to use the probiotics that have been shown to improve constipation. Three different probiotics have been found to improve constipation and there’s reference one, two and three in the bullet here.

In fact, one study even directly compared two different formulas in a placebo-controlled fashion and found either probiotic formula worked, and we have a reference here. These studies mostly used category one and category two. Bullet four, various types of probiotics have been found helpful for inflammatory bowel disease, mainly category one and category two but also a growing number of studies in category three. I listed a number of references there. At least two different categories have been shown effective against SIBO with three supporting references. Finally, urinary tract infections have been reduced using category one probiotics and different formulas were used within the category one formulation for urinary tract infections. To say that we need a specific probiotic strain, I think it hearkens to a misunderstanding of how probiotics work. Probiotics are not drugs. Probiotics work to improve one’s gut health. As a derivative of improved gut health, we can see a number of the symptoms and conditions improve because of the gut-brain connection, the gut-skin connection, the gut-thyroid connection, the gut-immune connection, the gut-joint connection.

It’s more about finding probiotics that help to balance and heal the microbiota in the gut than it is the probiotic that’s going to lower your cholesterol, improve your mood or what have you. Be wary of these claims. I’ll come back to the fact that when we look at this collectively it leads to a simple probiotic protocol and reiterate the quote, “The evolution of knowledge is towards simplicity, not complexity.” This is a more evolved perspective on probiotics. We don’t use them condition-specific. We use them personalized to the individual.

Probiotic Cautions

Moving on, a section regarding cautions with probiotics and I list where I believe to be two viable criticisms of probiotics, “We need more and better quality data” and “the type of probiotic used in research studies has varied, thus making it difficult to create any clinical recommendations.” These are the two main criticisms. “We need more and better quality data,” one, and two, “The types of probiotics used in the research studies has varied.” It’s very difficult for us to say what the recommendation for the exact formula or dosage should be. Let’s address these one by one.

“We need more and better quality data.” There’s a graphic here that I really like which is essentially the pyramid of evidence-based medicine. You have cell studies and animal studies at the bottom, and at the top, you have clinical trials, and above that at the pinnacle, you have summaries of clinical trials, i.e. meta-analysis or systematic reviews.

Now, the criticism that we’ve talked about from some notable and respected gastroenterologists like Pimentel (I appreciate the criticism, but I also disagree with it) is we need larger and better trials and we lack what’s termed as heterogeneity in the data, meaning not all the studies are exactly the same, using the same setup, the same design, the same probiotic formula, the same dose.  We don’t know what strengths you recommend for IBS patients, which is true, but when you understand it in the context that I will lay on in a second here, you see how foolish that handwave is. We have research for something like rifaximin and for probiotics that both occupy the apex of the evidence-based pyramid, meaning they’re at the tippy top. Now, you could argue that the data for rifaximin is higher up in the tippy top of the pyramid. We’re already at the pinnacle of the pyramid, but within that pinnacle, which if you’re in that pinnacle, you’re at the bullseye, but the data for rifaximin is a little bit better.

We could say that the data for Rifaximin is akin to a Ferrari, a $250,000 car, but just because the data for probiotics isn’t as good doesn’t mean it is not good quality data. The data for probiotics would be akin to a Porsche, a $65,000 car. To say that a Porsche is a junk vehicle or that probiotics research is inadmissible in advising clinical practice is silly because we have 23 randomized clinical trials for probiotics and IBS.

We have six with rifaximin. The six with rifaximin are larger and they’re all using the same drug. The 23 for the probiotics are smaller sample sizes and they use different probiotics which can frustrate researchers sometimes because they want to see just the one formula that’s been used and replicated. If you get outside of that evidence and limited thinking, you see that “We have good data for both these therapies and sure the data for rifaximin is a little bit better. It’s the one antibiotic used and the trials are larger.”  Agreed.  But is that disparity enough to say that we shouldn’t be routinely recommending probiotics for patients? Incorrect in my opinion. A side note, something that we are working on right now is a cost-savings analysis for how much we would save the US healthcare system or just, any healthcare system really, it doesn’t have to be the US, if gastroenterologists were performing a trial on a probiotic before going to rifaximin. If you look at a probiotic trial, let’s say as a generous estimate, meaning highballing it you’re talking $150 compared to Rifaximin which is about $1,000, just the cost savings alone would be massive.

Pretty strong argument to refute, “We need more and better quality data before recommending the probiotic.” Sure, we always could use better data, but we can’t say we need better data before we recommend a probiotic. I think it’s a dodge to say, “Well, I’m not against probiotics, but I don’t provide my patients any advice there.” I think conventional gastroenterologists should step up their game a little bit, do a bit of research, find a company that follows the appropriate quality assurance practices which we’ll highlight in a moment and start giving their patients some recommendations. I guess that’s what we’re here in natural medicine to do. I also don’t want to be too critical of the gastroenterologists, but those are just some thoughts on that piece there.

We also discussed that the types of probiotics used in the research has varied and we already touched on how, depending on how you look at it, that’s a good or a bad thing. I look at it as a good thing. It is a viable criticism, but we also have a number of research studies showing that different antibiotics work for small intestinal bacterial overgrowth. Guess what? If someone has a reaction to rifaximin, a doctor, a conventional gastroenterologist most likely would use a different type of antibiotic. To say that because different antibiotics have been used to successfully treat SIBO invalidates the ability of us to recommend antibiotics for SIBO is really silly. Again, these are not valid criticisms in my opinion.

Quality Assurance

Quality assurance, this is fairly important and I didn’t realize how important it was until I double-checked some of these quality assurance practices when reviewing the evidence for this article. The thing I always struggle with is supplement companies are notorious for hiding behind quality assurance as a method to sell you their probiotic or gouge you with pricing. This doesn’t happen at the lower end supplement end of the scale. It happens at the higher end. The consumer who’s looking for the best will sometimes be hoodwinked by the purist and the best with claims that a monk prayed over it and it was organic soil and biodynamic and harvested on a full moon so they can charge you more than maybe justifiable otherwise.  There is a middle ground here that we want to strike. We want to be sensitive to cost, yes, but we also don’t want to drive the price up when we’re not going to incur any additional benefit or safety from that higher price.

The two most common problems with probiotics are 1) not meeting their label claims and 2) containing potentially harmful organisms. The practices you can use to ensure this doesn’t happen to you is to make sure that whatever probiotic you use, and obviously all of our probiotics hit these criteria, perform genetic testing to identify what the strains actually are. That your probiotic is free of all major allergens like shellfish and gluten, have a validated potency, meaning if it says 10 billion CFU per serving on the label, there’s actually 10 billion per serving. That the facility follows GMP or good manufacturing practices and that there is independent laboratory analysis. The independent laboratory analysis will hit the potency, the free of allergens, genetic identification.

Why is this important? There are a few citations here that are quite striking. The Journal of Biotechnology and Equipment found none of the 26 commercial probiotics assessed fully supported their label claims and some even contained unacceptable potentially harmful, microorganisms.”

The two common problems were 1) low concentration of viable cells, meaning you’re getting ripped off, they’re telling you there’s 10 billion and there’s actually 1 billion and 2) the presence of undesired potentially harmful organisms.  The Journal of Clinical Gastroenterology and Hepatology concluded regulation of probiotics is inadequate to protect consumers and doctors. You have to do your homework. The journal PLOS One found only half of the probiotics they examined had the specific strains listed on the label, which varied considerably by store. Only half of the probiotics that you grab and look on the label, it says lactobacillus acidophilus, only half of them actually contain lactobacillus acidophilus. Shocking. A study at Labdoor found 43% of the probiotics they assessed contained less than half of the amount of probiotic listed on their labels.

Now, are you starting to see why people have a variance of experience with probiotics? This is why. The Journal of Bioinformatics and Drug Discovery concluded regulation of probiotics are loose, so the safety and effectiveness of most probiotics is decided by the manufacturer. This is a big deal. I’ll share a little backend business tidbit with you. We recently obtained a list of manufacturers of probiotics. I wanted to see what other additional options were out there for us. This was a long list. I don’t know how many but well over 100 different manufacturers and we had our team go through and determine which companies met these quality assurance practices.

Over a hundred companies listed, five. Five met these quality assurance practices. On the one hand, I cringed when people try to hide behind quality assurance as marketing BS. With probiotics, this is fully legit and something that you must be looking for. We will soon be updating our labels to put all of these on them because I think the consumer needs to understand how important this is with probiotics because obviously here, you could say 50-ish% of the time if not higher than that, people are getting ripped off with their probiotics. They’re getting not the right strains, potentially harmful strains or the probiotic is not nearly as potent as the label is claiming it to be.  This is likely a large part of the reason why people like Phyllis who have tried other probiotics had not responded or had negative reactions, try our probiotic protocol, the 3 for BALANCE and they see results they haven’t seen, in her case, in three years of tinkering.

Yes, I understand our probiotics are not the cheapest in the market. They’re also not the most expensive, but they do hit the important quality assurance measures. Hopefully, that’s helpful. That really opened my eyes and it helped me to understand why potentially some of our patients were seeing results with our probiotics when they hadn’t had success previously on other probiotics.  It was somewhat perplexing to me “Why didn’t Phyllis see any result from probiotic prior? Why did she react negatively and why do I hear so many people saying, ‘Well, I’ve reacted negatively to probiotics and then my clinical experience doesn’t reinforce that’?” The quality assurance measures that we go through and good companies go through might be a large driver to that observation.

Storage of Probiotics

Our next section, do you probiotics require refrigeration? The bottom line, no, not by the consumer. As long as you’re storing them at room temperature, you’re fine. Short-term consumer storage does not require refrigeration. Longer-term storage by the manufacturer, months and months and months, yes, they should be refrigerated with the exception of category three probiotics which don’t require refrigeration at all. Category one and two do require refrigeration by the manufacturer, none of them require it by the consumer. Not a bad idea to keep them in the fridge, just as a, I guess, pseudo-safeguard, but you don’t need to.  Don’t worry if you receive a probiotic and the freezer pack is not frozen or you’re traveling and they’ll be out of the fridge for a day or two. It can save you a lot of heartache by just understanding that. I list a number of quotes here.  The Journal of Microorganisms in 2019 states, “Probiotics may be incorporated in dietary supplements and other dry food matrices which are expected to have up to 24 months of stability at ambient temperature and humidity.” There are a few quotes here with journal citations, but essentially you’re okay. Now, hot temperatures are bad. Over 104 degrees Fahrenheit will be damaging. Don’t put them in your morning oatmeal or tea or coffee, but don’t freak out about refrigeration either.

Who Shouldn’t Use Probiotics

Who should not use probiotics? The NIH states that probiotics are generally safe, even for premature infants. I’ll quote, “Given the large quantities of probiotic consumed around the world, the numbers of opportunistic infections that result from currently marketed probiotics are negligible. For example, probiotics have been administered to thousands of newborn infants including some who are premature without a single case of sepsis or significant harm.” Who should not use probiotics? Those who are critically ill. The Journal of Expert Opinions on Drug Safety recommends the following. “Critically ill patients in intensive care units, critically sick infants, postoperative, hospitalized patients and patients with immunocompromised complexity were at the most risk.” Continuing, “While the overwhelming existing evidence suggests that probiotics are safe, complete consideration of risk-benefit ratio before prescribing is recommended.” Essentially what they’re saying is – people who are critically ill.  I’ll be a little careful with the statement, but because you’ve had one or two low white blood cell findings on your lab work, does this mean that you’re critically ill? Probably not. I would consult with your doctor if you’re not sure, but saying you are critically ill or immunocompromised is a significant statement.

I just want to be careful because people ask us, “Well, I had low monocytes on one test six months ago. Does that mean I’m immunocompromised?” Again, I want to be careful not having all the contexts and not to mislead someone, but probably not. If your doctor has told you you’re immunocompromised, if you’re in the hospital, if you are critically ill, yes. Otherwise, you may want to get an opinion to qualify if you are immunocompromised. If you’re not, wait a little bit of time and get yourself a little bit healthier and then use your probiotics. Also remember that even for premature infants, there have been benefits shown.

Use in Infants and Mothers

The next section, “Probiotics safe and beneficial for infants and mothers. Some of what the research has found, less colic, less irritability in children. This is less diarrhea, fewer spitting episodes and fewer respiratory infections and different benefits are connected with different strains which suggest a multi-strain formula may be the best.” In fact, a systematic review and meta-analysis looked at 44 studies involving premature babies. Probiotics helped prevent serious gastrointestinal illnesses that are sometimes fatal for very low birth weight infants.

We cite some additional benefits, being safe for even premature infants, protect against infant fungal overgrowth, reduce the risk of respiratory tract infections, prevent excessive weight gain, can prevent preeclampsia, reduced vaginal bacterial infections for mom.  There’s a number of benefits.

We also created another table, what type and dose of probiotics are best for infants. You see that there is a wide range of probiotics that have been used for infants. Why I list this is because moms have a notoriously hard time taking my advice when I say, “Use our Lacto-Bifido blend probiotic for your child.” Now, if I put Lacto-Bifido blend probiotic infant and it was the same thing, I’m sure moms would gobble it up. I understand moms being cautious. 1,000% understand, but we don’t want to be, ignorantly cautious, meaning that we just need to see something on a label, in this case, “infant”, and we automatically presume that that means somehow the strains are the best for infants.

When you look at the 10 or 11 studies that we cite, there is a range from one single strain to about 10-ish different strains. There is an array of different probiotic species that have been used. The infant gut is probably not terribly different from the adult gut. There, of course, are some differences, but in terms of the probiotic needs not vastly different. We put this table in here for moms, so they can see here are the 10 select studies that have used probiotics in infants. They can see exactly the dose, exactly the strains, and hope that will help them be more comfortable when selecting a probiotic for their infant. I recommend our Lacto-Bifido blend probiotic.

Not a Substitute for Medical Advice

As we move here to a close, the final section or two here, probiotics, your doctor, your healthcare, I want to be clear that probiotics are not a substitute for medical advice. If you have a serious condition, a trial in probiotics is warranted. Does that mean you should not see your doctor if they want to have you followup or if you’re feeling pretty ill? No. Keep your doctor in a loop. Probiotics can be very helpful, but don’t ignore the requests of your doctor. If you’re not liking what your doctor is saying, get a second opinion.

When we say see your doctor, it doesn’t mean see the doctor that you don’t like. A second opinion is definitely included underneath the umbrella of checking with your doctor. If you don’t like your doctor, find another doctor, get a second opinion. 

As probiotics are considered as part of a larger health plan, remember that the sequence and integration of probiotics into that plan is important. Healthy Gut, Healthy You lays this all out. We start with finding the ideal diet for your gut. We then move to probiotics and other supports like enzymes. After that, there’s a consideration of herbal antimicrobials, maybe even elemental diets, finishing touches with fiber and prebiotics. That all is really elaborated on in Healthy Gut, Healthy You. I would see that if you need more help. Probiotics clearly can be very, very helpful and for a notable subset of the population, when combined with a good diet and lifestyle, may be all they need.

For those who need more, don’t make the mistake of giving up on a probiotic protocol that’s helping you. Layer in additional therapies if you only saw, let’s say, a 30% improvement from the probiotics. It’s not all or none. Sometimes, you have to Lego-block these different therapies together to build you to the level of improvement that you’re looking for. 

Episode Wrap-Up

That is our comprehensive probiotic article. I hope you will check it out. I hope you will refer back to it for the references, for the images, for the infographics, for the guidelines and I hope you will share it with people.  There are, frustratingly, self-proclaimed experts on whatever they’re proclaiming to be experts on who clearly don’t know much about probiotics. I get frustrated when those who are resting behind their credentials and handwaving and making these vague statements about probiotics haven’t done the hard work to understand how probiotics can be used, what the clinical evidence shows nor I suspect do any of them have clinical experience using probiotics, knee-to-knee with patients.

Please share this information because it is really unfortunate that people are being given incompetent advice regarding probiotics. Competent advice could lead to really notable improvements. Incompetent advice harms people because if people then go to other therapies that aren’t helping them or potentially are even more invasive to quell their symptoms, then that’s a real loss and a real travesty. There are also the cost savings.  If people are being given rifaximin before probiotics. The delta there is huge. $150 to about $1,000.  I hope a lot here was helpful.  If you have any questions, please let me know. When you hopefully go on the 3 for BALANCE Probiotic Protocol, please let me know what you noticed. I’m always looking to collect these reports from people because as you may know, we share these beneficial case studies. This seems to really give people hope who sometimes are in need of a little boost and also just provide some anecdotal evidence that, yes, these things can have a big impact. That is it, guys. That is the comprehensive probiotic article narration by me. Hopefully, you found it insightful. Please keep me abreast of your experimentation and the results that you see. All right, we’ll talk to you next time. Thanks.