In this episode of The Dr. Hedberg Show, I interview Gary Stapleton of Aerodiagnostics Laboratory answering the question, “What is the best SIBO test?” We covered a lot of ground about the ins and outs of SIBO breath testing including the best methodology, glucose vs. lactulose, how to properly perform the test, proper test interpretation, hydrogen sulfide, when to retest and much more.
Gary is the founder of Aerodiagnostics Laboratory which I personally use in my practice and highly recommend to everyone who wants the most accurate SIBO test on the market today. Combine that with the best customer service and support and it’s a no-brainer to use them for your SIBO testing.
Below is a transcript of the entire interview with important links at the end:
Dr. Hedberg: Okay. Well, welcome, everyone. This is Dr. Hedberg and welcome to “The Dr. Hedberg Show.” I’m excited today to be talking to Gary Stapleton. And Gary is the founder of Aerodiagnostics Laboratory. And this is the laboratory that I use for small intestinal bacterial overgrowth testing. Their lab offers non-invasive hydrogen and methane breath testing. It’s the lab I’ve been using to test for SIBO because the quality is really unparalleled in the SIBO world and I’ve been very, very pleased with the quality of the results I’ve been getting and the customer service. So we’re going to be talking about some really interesting items today about SIBO and SIBO testing. So, Gary, welcome to the program.
Gary: Oh, thank you, Dr. Hedberg. I really appreciate joining today and I look forward to discussing SIBO and breath testing, hydrogen and methane breath testing with the audience.
Dr. Hedberg: Excellent. Yeah, it’s good to have an expert like you here because this is really a hot topic. I mean, the prevalence of SIBO is continuing to grow and we’re seeing it more and more. And then, of course, our IBS population really struggles with SIBO, for the most part. So why don’t you start by just talking to us about hydrogen and methane breath testing and how it works in the diagnosis of SIBO?
Gary: Yes, so thank you. And please feel free to interject if there’s something that I’ve said or am in the process of saying that might be beneficial as well. So hydrogen and methane gas, for those listening that aren’t aware, are not produced by the body. Hydrogen and methane gases are produced by bacteria that is fermenting. So the way that the test works and why it’s so incredibly important to prepare correctly, to use the right devices correctly and to administer and ensure that your devices are operating correctly, to ensure that we’re measuring hydrogen and methane gas appropriately, it all begins with the preparation. And then, if you prepare correctly, which means you’re moving food from the GI tract, there…even if there’s bacteria, there’s no gas being produced because the bacteria, if it’s there, needs to be fed to ferment and to produce this gas.
So if you have bacteria in your small intestine and you’re not supposed to have bacteria in your small intestine, I believe it should be less than 103 colony-forming units in the small intestine. If there’s bacteria there and you’ve prepped, which means you’ve removed all food, your baseline breath sample should be relatively low to no gas because, again, the bacteria’s there, it’s not being fed.
Now, after that baseline sample, you ingest either glucose or lactulose as a substrate that has been validated to ensure appropriate measurement of gas levels inhalation of small intestinal bacterial overgrowth. When you ingest either that glucose or lactulose, that is a food source. And that food source will now feed bacteria, if it is there. That bacteria will ferment or rot and the gas that’s produced, either hydrogen or methane, will diffuse through the blood and exit via the lung air.
I’ll deflect for just a moment and say everyone is aware that there’s a third gas. It’s called hydrogen sulfite gas. And in our experience, and I know that some of the SIBO thought leaders and some of the very good clinicians that are treating SIBO today may suggest that there’s a higher prevalence of hydrogen sulfide, there’s not a lot of data on that and we’ll talk about that. But I will tell you we’ve run nearly 20,000 breath tests and by the definition of utilizing a lactulose breath test and having a flat line, we’re only seeing hydrogen sulfide suspicion 1 to 2%. So it doesn’t really occur that often, from our perspective.
So back to how does the test work. So if you’ve now prepped correctly and then you’ve taken a breath sample and then you ingest either the lactulose or glucose, now that lactulose and/or glucose is traveling through the small intestine. And when it meets up with bacteria, it will ferment and leak gas into the blood that exits via the lung air. We capture that and then it’s tested in the lab. If it happens between zero minutes…and again, this is another of points that we will probably get into later, but the way that the test…the gold standard interpretation has been if you have a rise of gases between 0 minutes and 120 minutes, that would be a positive indication that there is bacterial overgrowth.
There are some newer data and some newer perspectives that look only at 90 minutes. And, from a laboratory perspective, it’s accurate data. We want to provide you, the clinician, with accurate data. If you’d like to interpret these looking only at 0 minutes to 90, you can do that. You can look at 0 to 120 and challenge the more distance, which is what we recommend, considering then we can do that. And, again, we’ll talk about that a little later.
If your choice is lactulose, then that lactulose will pass into the large intestine. And because there is bacteria, and should be, typically, you have elevated levels of hydrogen and/or methane gas when it gets into the colon. With glucose, it is absorbed and you still get some gas levels. But not necessarily elevated through the last three test tubes. Okay? So this is how the hydrogen and methane breath test actually works.
What I like about this test, with the total accuracy by the studies that were involved with it, over 90%, but what I like about it is that it’s binary. If you have hydrogen and/or methane gas within that first 120 minutes or 90 minutes, that is evidence that there are bacteria producing gas. It’s the only way if the patient prepared correctly. The only way you would get that gas. As I mentioned earlier, the body doesn’t produce the gas. So that’s the way we do that. So I’ll pause there, Dr. Hedberg, and see if that answers the question.
Dr. Hedberg: Yes, yes. That’s a great overview. And one of the ways I explain it to patients is just like you’re putting gasoline into a car and the engine burns the gasoline and then the gas comes out. And the bacteria are basically the engine burning that fuel that you put in. And it could be either glucose or lactulose, like you said. So can you talk just a little bit about your specific methodology? Because not all labs are equal in this. And I learned that early on. So how do you ensure the data you’re seeing is accurate?
Gary: Well, thank you for that question. I will tell you this is why I founded the laboratory a few years back. I think it’s three and a half years ago. My wife, who is a physician, has owned and operated her own diagnostic laboratory in the pathology world. I’ve either owned or operated or have run large diagnostic laboratories during my career. My wife was suffering from SIBO and, of course, like many of your patients, was asked to take a breath test.
So we live in Boston and the first test was asked to go to a very well known hospital in Boston. We’ll refrain from saying the exact one, but I assure you, it’s a very good one. And the first process was that she had to call to organize when they would go there and have the breath collected. So there was a lot of back and forth. It was very inconvenient. And, finally, it was settled that it was going to be on a Wednesday, in Boston at 1:00 in the afternoon.
Well, as everyone knows, you have to prep for this, which includes 24 hours of a limited diet. Well, 12 hours of a limited diet and 12 hours of a fast. Clearly, you don’t want to be fasting all morning. Typically, you fast overnight. So it’s inconvenient for the patient there. Then, when we got there, it was to go down in the basement. And now you’re in the basement for three hours with upwards of 20 other people having breath collected. No internet, no phone. For people, this is very inconvenient for obvious reasons.
And then, when the test was over, the collections were actually done, you would have . . . first of all, the prep information was not consistent with how the test was actually validated. So that led to some inaccuracies. But then, the clinician or the technicians that were collecting the breath, you could tell that they were trained by someone else, not by the equipment manufacturers or anyone directly. Almost like whispered down the lane. So things have changed and they didn’t really know how to work with the devices and different things. So we were suspect from the very beginning. Needless to say, it was an inconvenient process and it wasn’t that good.
So the next one was we received a kit at home because we weren’t going to try again. And it was obvious that the kit was a homemade kit. The most important thing, and this goes to the question, how do you ensure accurate results, the most important thing is that you have very direct and personal involvement with that patient to help them with the prep questions. The prep is very specific.
Now, any clinician can change this, but the test has been validated on the preparation, meaning that the first 12 hours, you eat from a limited list of foods. They are very straight, very direct: chicken, fish, eggs, white rice, white bread, white potatoes. Now, there will be labs that argue that. There will be clinicians that will vary from that. I don’t know what to say, other than if you read the data, the data says chicken, fish, eggs, white rice, white bread, white potatoes. And that’s what we coach to.
So when we send a kit directly to a patient, we don’t ever drop it at a clinician’s site. All that does is put work on the staff. And you risk variability again because you’re the lab, you start working with an office, you train the office, they usually have an in-service. You train them on the prep and on the collection and everything. You’re putting all the work now on that office and then office personnel changes. So when they change, what do they do? They train the next person. So, again, whispered down the lane. So all of a sudden, chicken, fish, eggs, white rice, white bread turned into “meat.” So now, we’re having red meat or sausage or whatever. And rice turned into brown rice and pork fried rice and all sorts of things, when it’s white rice.
This is incredibly important because the prep is so…when we get an order from a clinician, they simply have it pre-populated with all the information we already know about that office and then they just give us what we don’t know, which is the patient information. And we take that order and we immediately get a kit FedExed out to that patient. The patient gets it. When we know that the patient received it, then we outbound call that patient to offer to answer any questions, whether it be on collection or whether it be on the preparation or whether it be on return shipping or billing or whatever it might be. That helps to reduce the variability.
So now, we’ve got good prep. Now we know they know how to use it. They know that they can contact us 24 hours a day for assistance, whether it be on any of those items. And now they are using a kit. That kit has to have data on it that confirms that it collects and transports true lung air. Because if it doesn’t, then you’re taking a guess at whether or not you are actually measuring what you need to measure, which is alveolar air.
It can’t be the dead air space in the mouth. It can’t be room air. So what we do is we personally chose QuinTron-branded kits and devices. And that was after an exhaustive review of everything that’s built. I’m an independent lab. I can buy any kits, any machines. I can get my own GC. I can make my own kits if I wanted to. But I didn’t want to. I wanted to buy the best that was available and that had data on it so that I knew I was giving that accurate answer.
So what we did was we buy these kits. They’re like vacutainers. Like when you draw blood, except we’re not going to puncture the patient. If you can envision this, it is a device where the patient will begin to exhale. There’s a needle and there is an evacuated, sealed test tube. Not opened up to room air. You puncture, you’re exhaling, that alveolar air is going through the needle into the test tube. And then, to remove that test tube when it arrives at the laboratory and it has data on it, that it transports correctly and holds that content. Well, when it gets to the laboratory, it is, again, punctured. Never opened. And it’s vacuumed out, the sample. And that sample is then interrogated. And that’s how we know.
But wait. We know now that we collected and used the thing, we know you prepped right, but how do we know? How do we know the machine is reading it right? Well, we calibrate our machines. Every five tests, it’s calibrated. Which means in four different ways. We have a known hydrogen tank, known methane tank, known carbon dioxide tank. And we put a sample in each of those through each machine every five patient tests. And the machine has to get it right. If it doesn’t, it’s recalibrated. We also do a negative QC by taking a sample of room air. And it has to get that right.
So now we know we have accurate data and now it becomes interpretation. So the question was about accurate data. And if you look at all the laboratories that are available now or the hospitals, yes, you can get coverage at a hospital and maybe the patient doesn’t have any out-of-pocket or you can get a lab that’s willing to do it for less. Yes, you can do it for less if you’re not buying these good pieces of equipment or these good kits. Yes. If I were to make my own kits, buy my own components, I could probably do this for less. But that’s not going to help if the data is inaccurate.
The last thing I’ll say about inaccuracies, what’s the CO2. You did mention that. Well, carbon dioxide is at standard levels in alveolar air. Constant levels. And it’s in trace amounts in non-lung air. So we’re looking for the right number of CO2, the right level of CO2 in each sample to validate that the right kits, the right shipping, everything happened right, the right prep. Everything happened right and what we’re actually measuring is lung air.
Because if I’m measuring room air, dead air space and giving you a low number, then I’m giving you a false negative. So when this CO2 is correct, then that means…and the machines are calibrated so we know that those individual data points are right, now the clinician can interpret that data based on any interpretive method, whether that be the Rome Consensus or the North American Consensus or some of the peak values. And we’ll talk about that.
Dr. Hedberg: Excellent. I don’t know if controversial is the right word, but let’s just talk a little bit about the differences between glucose and lactulose. This is something that a lot of it seems to be practitioner preference, but…and, of course, some of it has to do with how to interpret those two. But there’s a lot of research out there. And I think the main difference that I’ve seen is the number of false positives with lactulose compared to glucose as really one of the main potential issues with the differences. But when it comes to lactulose, my understanding is a lot of it is about the interpretation. So can you talk a little bit about the differences between those two?
Gary: Sure. And thanks for that. I will tell you that when I first opened the lab, I was told SIBO has two substrates that you can choose from, glucose or lactulose. Okay. Well, we’ll get both, I guess. Didn’t know a lot about it. And then I started looking into it and lactulose is a prescription in the United States. So if you’re a patient and you want to get a test without going through a clinician, which we don’t suggest, but if you do, you can’t get that. You’ll get the glucose. Or if you don’t have a prescription. So that’s one. When I thought about that, I thought, “Well, there are many clinicians. There are dieticians in various states.” Naturopathic clinicians in various states that can’t order lactulose, which still doesn’t make any sense to me, but that’s another story.
But regardless of that, you have that issue. So I thought, “Well, there’s a lot of talk about if you’re not doing lactulose, you’re using the wrong one.” And then I thought, “Well, then why aren’t both available?” So I did a very deep dive into all of the studies with regard to glucose and lactulose. Now, let me just put a disclaimer here. I am sure that someone could find one that will be disparate from what I’m going to say here. But I will tell you, at the time, which was only a short two years ago when I did the exhaustive search looking at glucose versus lactulose, a surprising answer came out. Glucose, by far, in every study that I saw, had a higher sensitivity and specificity. Period. End of story.
Now, I think that is somewhat misleading if you don’t tell the whole story. So here’s the whole story. To your point, lactulose is extraordinarily good for use with the SIBO methane breath test, as is glucose. The reason, to your point, that its sensitivity and specificity are lower than glucose is because of the false positives. So let’s drill down into this. This is really pretty simple, actually. Lactulose is a laxative. In some patients, it can increase gut motility.
If we’re looking between 0 and 120 minutes or zero and whatever minutes you want to look at, there is an opportunity for that lactulose in that given patient to go through the small intestine faster. If it does, then any distal points on that, you might get a rise of gases and think you’re in the small intestine but you’re in the colon. Because there is bacteria in the colon. You will have gas there.
So that’s why it has false positives associated with it. I’m not going to say this is why the North American Consensus is [Inaudible 00:20:31]. I don’t represent that consensus at all. I am just saying there is a drive toward not looking toward 120 minutes for that very reason. They want to limit the false positives.
From my perspective, I think the data is the data. We give the clinician the data and allow the clinician to look at that data in conjunction with the clinical impressions that they have of that patient. Only the clinician can make the diagnosis. The breath test is not a diagnosis because even though it’s binary if you have gas, there’s bacteria, you have to take that into consideration with the substrate, with the timing and with what you’re seeing with the patient.
Does the patient have bloating, cramping, nausea, joint pain, restless leg syndrome, skin manifestations like rosacea and/or psoriasis? Are there things that would lead that clinician to believe they’re dealing with SIBO? And, by the way, they’re chronic, regardless of what week. So when you have that and you have the substrate being used, then that’s where you get the best diagnosis and you can use the full data set.
So glucose or lactulose? What you’ll hear or see if you scan the internet or hear from the [Inaudible 00:21:49] is that glucose is good for more proximal infections, lactulose is good for more distal infections because lactulose is not broken down in the small intestine and it’ll pass through into the colon. Glucose will be absorbed in the small intestine so you’ll miss a distal infection.
Well, the studies all dispel that. The studies were very clear that had a high sensitivity and specificity in all the studies. And I see, from running all the glucose tests, and we run a lot of them, that we’re seeing the data throughout the small intestine. So even though it’s a good…I don’t want to say theory, but it’s a good perspective that many of the very well known and respected SIBO thought leaders say…and I’m not trying to disagree with their perspective. I actually see this as pretty reasonable to me that if it’s absorbed in the small intestine, maybe you won’t get all the way through. Maybe you’ll miss a distal infection, right?
But the fact is that the studies don’t back that up. And the fact is that we’re seeing the gas in these tests. And I’ve had clinicians that will order both. I do not suggest that. I see some clinicians doing that. I think from a convenience/inconvenience perspective to the patient and from a cost perspective, I don’t suggest that. I will tell you every single time, every single time that we’ve run a SIBO and lactulose on the same patient back-to-back days, the same answer comes out. They’re either both positive or both negative. So these are good substrates.
So here’s one thing that I will say. And I’ll be asked this a lot. “Gary, why would you recommend lactulose, then, if the sensitivity and specificity of glucose are better?” Good question, right? And I do recommend lactulose when you can get it. Let me tell you why. There’s one benefit. One single benefit, in my opinion. And that is for your negative tests. You have a negative glucose, it’s negative, right? Negative is negative.
We did all the accurate stuff, used everything, calibrated the machine. Negative is negative. If you have a negative lactulose test but you don’t have elevated gas levels in those last three test tubes, then we have to put the brakes on, and we do, and we call the clinician. And I think I’ve even called you, Dr. Hedberg. Maybe I haven’t.
But I call many clinicians that use lactulose. And what I’ll say is that I expected to see elevated levels and I didn’t so we have to talk about a few things. We ask roughly nine questions that we have to review to help me understand why I don’t have a rise.
And here are some of them. They didn’t drink the lactulose. The lactose is a syrup and they didn’t mix it with water. They had some sort of flushing effect of the bowel, like use of antibiotics, heavy laxatives. They were on an elemental diet. That sometimes can have an effect where you don’t have a rise in the third hour of the test. And then the last one is hydrogen sulfide. So that’s the reason for lactulose, if anything. But I will tell you that you can do the same thing with glucose. Why? If you have a negative and you have SIBO symptoms, then we should question with those nine questions.
Dr. Hedberg: Right. Yeah, one of the most important things there is the patient presentation, how they’re feeling, how their symptoms are changing. I mean, it’s not just with SIBO testing, but any tests that I run, you always have to look at the patient and what they’re feeling and make the best decision in that regard. So there are a lot of different ways to interpret these tests. I mean, you said earlier it’s very binary. If the gas is there, it’s there. Do you have anything you’d like to say about the different approaches to interpret these tests and which way you prefer?
Gary: Sure. I will tell you that I have a personal preference, if I were doing a test for myself or my family, my personal preference for how I would look at the data. I’m going to tell you that my specific laboratory uses the gold standard of if you are using glucose and you have a three-hour breath test, which is the gold standard, and you have 10 test tubes being collected every 20 minutes, you’re looking for a rise in hydrogen gas of 12, a rise of methane gas of 12 or a rise of the combined 12. That’s glucose.
Lactulose would be a rise of hydrogen of 20, a rise of methane of 12 and a rise of the combined of 15. We also, based on the very good work that Dr. [Pimentel 00:26:52] and his team have done on methane when there’s constipation present, you use…it has been recommended by that group and many treating clinicians that the lower threshold of 3 parts-per-million of methane gas with constipation would be an indication, based on the work that was done there.
Now, there is, and everyone’s aware of it, a new North American Consensus. And I don’t represent that consensus, but you’ll see that there are differences in collection times, they are looking at 0 to 90 minutes, there’s a threshold for methane of over 10 and some other things. You can read about that. And I have a lot of questions. Why are you not changing over the interpretation that you put on your reports, the North American Consensus? I would love to. I would love to if it were a study. It…by definition, its consensus was a survey. So 17 very good, very well-intentioned and very well-thought-of clinical and research sites that were used as a part of that survey. So, essentially, a survey was sent out saying, “How do you interpret these tests?”
They got all the answers back, they came together, did some really hard work and they came up with their perspective on that. And through our advisory groups and different folks, we looked at it and said it’s just too difficult to apply that within our laboratory because we couldn’t point to it as a study with controls. Whereas the interpretive method that we use now has been arrived at…the consensus had been arrived at through studies with controls and it wasn’t an opinion of how clinicians treat.
Plus, we serve 27 countries and it was a North American consensus. And not everyone treats similarly throughout the globe. So we felt the most pragmatic approach would be to remain where we are until such a time that appropriate studies with controls have been able to validate presences or absences of bacteria.
Now, all that being said, all that being said, I think our job as a laboratory is not to tell you necessarily the answer. It is to make a recommendation based on peer-reviewed, published work. But most importantly, give you that accurate data, including carbon dioxide levels. Give you all the accurate data. Be there as a resource if need. Answer any questions that you have. If you want to apply the North American Consensus, you should. If you want to apply what some SIBO thought leaders do, and I agree with this, there’s just no data on it for me to operate that way, but let’s say you want to do a peak level.
Like some SIBO thought leaders will look at hydrogen. And if you’re using lactulose, we talked about having a rise of hydrogen gas in the small intestine of 20 parts-per-million or more. What happens if you don’t get the rise? What happens if your rise is 5, 6, or 7 parts-per-million but you have 20 parts-per-million or 30 parts-per-million of hydrogen and/or methane gas at 90 minutes? There may be reasons why you don’t have a rise.
It could be poor prep, it could be slow migrating motor complex. There are reasons why you may not have a rise. So some SIBO thought leaders say to go back to that whole binary nature of this. If you have gas, it can only be from bacteria fermenting. So if you have a level of gas that’s at that level, I’m less concerned with looking for a rise. And they can do that. You, the listener here, can do the same thing.
So going back to what I said when I first started the question, if it were me or my child and I saw 20 parts-per-million of hydrogen, I care less about the rise, in my perspective. If that correlates with the clinical impression and the clinician who’s treating that child of mine agreed, then I would be in agreement with treating.
Dr. Hedberg: Excellent. That’s a great overview of glucose, lactulose and the interpretation. Now, you had mentioned hydrogen sulfide gas earlier. Did you have something else you wanted to say about that?
Gary: Yes. I will say we’re in an exciting time. An extraordinarily exciting time right now. There will be papers that will be presented here coming up at DDW, Digestive Disease Week; and ACG, the American College of Gastroenterology in the fall and we’re going to learn a lot more there. There are researchers doing a lot of good work on hydrogen sulfide. I might disagree that the prevalence of it is where they are recommending. And we’ll wait to see the papers. It’s just from the information and doing the 20,000-plus tests that we’ve done, we just don’t see it. We just don’t see it that often.
And when you have lactulose, you would know because if you have a positive SIBO test and you don’t have a rise, you know you’re dealing with hydrogen sulfide. Excuse me. That’s a negative test. But I’m looking forward to the data. If the data will deliver us differently, I’m excited for it. So I’m excited to be able to do hydrogen sulfide gas testing.
So there are devices that are available right now. I don’t personally use them because I’ not comfortable with the data behind it. There are devices that are imminently going to be launched. Again, I would probably be less to the…I would really want to look at the data and what was validated and who validated it before I would actually purchase one of those machines. But I would if it were good.
Here’s the trouble. And someone could figure out something different. So maybe people that know things that I don’t know here as I’m answering this question. But hydrogen sulfide is measured in parts-per-billion, not parts-per-million like hydrogen methane gas. It requires, with the current sensors that are available in the marketplace today…and I’m not a device manufacturer, by the way.
So there are things I may not know. But from what has been told to me by many manufacturers of these products, that measured in parts-per-billion, it requires a large volume of gas. So it’s less likely to be available via at-home breath collection. If they can solve for all these things, I think it helps because we need to know if there are these three gases we should be able to measure all three accurately and deliver a result on all three.
Dr. Hedberg: So let’s get into some more rapid-fire-type questions, but please feel free to elaborate as much as you want to on these. So one question is when should a patient re-test following a treatment plan?
Gary: Okay. Current guidance is the kits will say two weeks because that’s the studies that were done to support that. Many clinicians will test anywhere from 10 days to 14 days. The reason for…and some are more aggressive, even starting at five days. But the reason there was the two-week recommendation is you want the effect of your treatment to be completed, the effect of that to determine whether or not you have the presence or absence of bacteria now. The reason for not waiting two weeks, and why many clinicians go around 10 days, is that if they didn’t get all the bacteria, which is common, then they don’t want to risk regrowth.
And with an elemental diet, you want to test the very next day. And the way we suggest in our laboratory is we will turn it around for you. It goes to the front of the line. So when you start that elemental diet, you start it so it finishes on a Monday or a Tuesday. Why? Because they’re going to FedEx that back to us and I don’t want it FedExed back where it sits all weekend. Because you’re going to have the patient do the elemental diet all the way up to…let’s call it a Sunday, right? And then they fast overnight and then they’re going to collect their breath, and then they’re going to remain on that elemental diet until we get the answers.
So if they expedite that kit back to us, and they can even choose to overnight it if they like, if they let us know in advance or the clinician lets us know it’s inbound, then we do that as a first run. So we look for that as it comes in and that’s the first test that’s reported out so that you can get to your patient and say, “Yes, we need to continue,” or, “We need to go to a different therapy,” or, “We’ve got it. You’re clear. You can go back or start this diet now.”
Dr. Hedberg: Right. Right. Okay. And there’s a term called “time gap treatment and recurrence.” Can you talk about what that means and why it’s so important?
Gary: Yes, absolutely. And I will tell you this. This is one of the most important things, if anything, that we can talk about here today. You hear often about SIBO and recurrence. And I’m not trying to propose that there’s not recurrence. There’s recurrence. But I don’t believe it’s as at the level that many that are treating SIBO think that it is. I think what we see a lot is patients that present maybe even to a primary and the primary says, “Well, I want you to go see so-and-so and you can talk to them.”
And then they’re either tested or not tested and they’re given some antibiotics. And then the patient starts to feel a little bit better because some of the antibiotics knocked down some of the bacteria count. They feel good, they’re on their way. SIBO patients have been sick for so long that their best gut day is our worst gut day. So they’re starting to feel better from some of the antibiotics and some of the treatment and they’re not tested or re-tested. So they just go on their way and three months later, the bacteria was never truly eradicated so it just truly repopulated and we’re back into this every three-month situation.
So the first thing I do when I get a second test on a patient…and we look at that and it’s a second test and there’s a long period of time that it’s positive again, we always pick up the phone and call the clinician and we talk to the clinician about that. We say, “What happened between this date,” here comes the time gap, “this date and this date?” So let’s say their first test was done in June 2017. Now we have a March and it’s positive.
And the clinician, the first thing they’ll say is, “Oh, that’s recurrence. That’s common.” Well, maybe. “Did you test back in June and get a positive?” “Yes, we did.” “Did you treat?” “Yes, we treated until August.” “Great. Did you test again?” “No, they said they were feeling better.” Well, that could have been that you knocked down the bacteria count. Now that some bacteria was left over, and over a period of time, it grew, it reflourished and now we’re back.
So test…well, suspect first, chronic symptoms. Test, treat and then many of the thought leaders will say to test again. Me, convenience and cost-wise for patients, if they’re still symptomatic, maybe continue to treat until they start to claim that they’re asymptomatic. That’s when you want to test to be sure you got it all.
Dr. Hedberg: Excellent. So a lot of patients will ask, “Do I need to stop taking this or that supplement?” So can you talk a little bit about prep for the test? So that would be diet and any stipulations on supplements they need to avoid?
Gary: Sure. So this is the way to think about it. The preparation for the hydrogen methane breath test, as we discussed earlier, was 24-hour prep: 12 hours limited diet, 12 hours of the fast. So the 12-hour limited diet, very straightforward. Chicken, fish, eggs, white bread, white rice, white potatoes. No varying from that. If you have vegans or otherwise, we tend to work with them, but we note everything and then we look at the results. And then, together with the clinician, we decide if we have meaningful data. And we do. And we do. There are ways to work through that.
But to your point about supplements and different things, there has been an ebb and a flow on this. So when I first started doing this work, there were no PPIs, no probiotics, no this. And then the PPIs got removed and the probiotics got removed. And now, we’re back to…there was just a recent article on a specific probiotic that seems to raise methane levels. So I think the most important thing to know is if you can remove for 24 hours or follow the limited diet and then the fast and the fast is water by mouth only throughout the test leading up to that, any products that are not essential to the care of that patient, whether they be laxatives or probiotics, if you can avoid those in the care of this patient, that would be best so that we get a good read for you.
Dr. Hedberg: Excellent. And what about diarrhea when we’re talking about collecting samples? What do we need to be worried about with that, if anything?
Gary: So we are working with the manufacturers right now to try to change the language that the patients see on that. Right now, it says if you have diarrhea, wait until you don’t have diarrhea. Well, we all know that many of these patients that are dealing with SIBO testing have diarrhea. And, really, it’s the wording that was chosen. So I think what you’ll see is it’s more about very strong, watery diarrhea.
So if you’re having that flushing effect, that’s why they had the diarrhea component in there, was if you have a violent, a strong diarrhea event and it’s water and it’s just shooting through the system, the potential for it to wash out or flush out bacteria is possible and we could get false negatives. So that’s why that was in there. I think it’ll be more of if you have soft stool or light diarrhea, it’s okay. If you have very strong diarrhea, try to negotiate the collection and prep when it’s not so strong.
Dr. Hedberg: Okay. Now, you’ve been very generous with my calls and, of course, with other clinicians, doing consultations if we have questions about a particular test that kind of leaves us scratching our heads when we look at a lab and it doesn’t seem to fit with the patient. So can you talk about why these laboratory and clinician consultations are so important?
Gary: Yes. Thank you. And I will tell you this, by far, has been the most critical aspect, in my opinion, of the entire testing process and the treatment process of that patient. You’re not…the clinicians are not expected to be experts in testing and interpretations and different things. We’ve done, as I’ve mentioned several times, more than 20,000 of these tests. We know this data very well. Our role in this is to support the clinician in that everything that they see in that test should match with what you are seeing as a clinician and the clinical impression of that patient.
And I can count on one hand the number of times that we were not able to match directly. And I think those times were because the one area we can’t tell you is the area that we’re blind to and that’s the preparation and collection side. We can train, we can talk, but we’re not there. So that can have an impact. As an example, if they don’t drink the lactulose or the glucose and we get a negative and you’re saying, “I see SIBO symptoms, but it’s negative,” there’s no way for us to account for that. So that’s where you have it on one hand.
So, oftentimes, whether it be time gap treatment issues, whether it be distal positives, whether it be a false positive because of a prep issue, the value that we have coming together and sharing and supporting each other, we…our clinical team, we work with all of you every single day. So there are shared experiences that we’re able to relay. “Dr. Hedberg’s doing this and Dr. Smith’s doing that.” And, oftentimes, we’ll connect clinicians to talk about a situation because they have a patient with MS or AIDs or whatever it might be.
And the value of us actually getting on the phone and talking with each other about this specific patient, not generalities, and that, to me, is the most rewarding part of what we do. And I’ll end with our tagline is, “Advancing healthcare into human care.” I take that very seriously. We want patients to get better. I want to see the success through the clinicians. And whatever little part we provide, which is just accuracy and convenience, then that’s the part that we serve in this world.
Dr. Hedberg: Great. So for any of the clinicians out there, if you’re using SIBO testing and not using Aerodiagnostics, I do highly recommend you use them. The quality is really unparalleled and the customer service is really unmatched in not just the SIBO testing world but the functional medicine testing world as well. And if you’re a patient and you need a SIBO test, you can always request that your practitioner or your doctor uses Aerodiagnostics for the lab test.
So this was a really great overview. We covered a lot and I really appreciate your time and you coming on, Gary. In closing, why don’t you just tell everyone how to connect with Aerodiagnostics, your website and any other online information you’d like to give out?
Gary: Sure. Well, thank you for that and thank you for hosting me today. Aerodiagnostics can be contacted directly at 617-608-3832 or toll-free at 844-681-9449. We also can be reached at aerodiagnostics.com. That’s with an “S.” So it’s aerodiagnostics.com. I am available if any clinician and/or patient would just like to talk about a situation or a difficult case.
The last thing I’d just like to say, Dr. Hedberg, and it comes from the heart, I reviewed that SIBO program you had on the Hedberg Institute and I think I told you this directly, I thought it was one of the most thorough SIBO classes that I’ve ever, ever participated in. So thank you for doing that good work.
Dr. Hedberg: Oh, thank you. I really appreciate the feedback. So that concludes this, everyone. I’m going to be posting all the show notes that we talked about on drhedberg.com and I’ll have links to everything we talked about, as well as Aerodiagnostics Labs. So look out for that. All right. Well, take care, everyone. This is Dr. Hedberg. Thanks for listening.
Aerodiagnostics can be contacted directly at 617-608-3832 or toll-free at 844-681-9449.
Gary Stapleton’s Bio
Gary Stapleton is the founder of Aerodiagnostics LLC, the only laboratory offering innovative and unique access to non-invasive hydrogen/methane breath testing.
– Previously, Gary served as the Chief Operating Officer for Calloway Laboratories, a Massachusetts based national toxicology laboratory. In his COO role at Calloway, Gary was successful resurrecting a urine drug monitoring business by increasing commercial access through effective model transition and by attracting new and innovative diagnostic tests.
– Gary began his career in the early 90’s with Astra USA, later AstraZeneca (AZ). He held numerous positions in his 14 years with AZ including sales, marketing, training, managed care contracting, executive account management, and senior sales management positions. Gary was integral in the successful launches of blockbuster pharmaceuticals including Prilosec, Nexium, Seroquel, Symbicort, Crestor, Rhinocort, Toprol-XL, Naropin, EMLA Cream, Arimidex, Accolate, Atacand, Pulmicort, Zomig, and Zestril.
– In 2007, he was recruited to Bausch & Lomb to lead the sales and marketing effort for B&L’s branded pharmaceuticals as the Vice President of Sales and Marketing in the United States. At Bausch & Lomb, Gary successfully led the commercial effort taking the branded and generic portfolios to record levels.
– Caris Life Sciences recruited him in 2009 to lead the growth strategy for the subspecialty (Gastroenterology, Dermatology, & Urology) anatomic pathology divisions. He launched the commercial Exosome offering, Caris’ first molecular diagnostic.
– Following his success at Caris Life Sciences, Gary served as the Chief Executive Officer at Lerner Medical Devices. He was specifically chosen by the founder to position Levia (Lerner’s flagship product) prominently in the marketplace.
– Prior to his extensive career in commercial health care, Gary served in the United States Marine Corps, initially stationed at Twentynine Palms, California after boot camp at Parris Island South Carolina.
– He did his undergraduate work at Long Island University followed by a Masters in Business Administration.
After many years in the health care space, Gary is excited to launch Aerodiagnostics, providing the highest level of diagnostic accuracy and customer service for patients and clinicians.