Immunoglobulins: A Therapy To Boost Immune and Gut Health

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Dr Ruscio:

Hey everyone. This is Dr. Michael Ruscio. And welcome back to Dr. Ruscio, DC Radio. Today I’d like to discuss and resurface a therapy that we introduced on the podcast, gosh, maybe two years ago now. And this is a therapy of immunoglobulins. I’ll detail what immunoglobulins are and how they work and how they may be able to help you, but what’s exciting about immunoglobulins is they are a unique therapeutic that you don’t really see other treatments offering the same type of distinct function. There are many different probiotics. There are many different antimicrobials. There are many different repetitive nutrients, inflammatory nutrients, and herbs—so on and so forth.

Dr Ruscio, DC:

Intestinal Support Formula immunoglobulins are unique, and we’ll detail that here. [I] just wanted to bring this to the surface because we had introduced this. And it’s something that we don’t discuss often on the podcast— because it’s not one of our starting point recommendations—and so it tends to get a little bit dwarfed by the importance of diet, mindset, lifestyle, and the earlier phase therapies that we harp on (namely probiotics and also elemental dieting). But it’s not to say that this is something that we don’t use often in the clinic and that does not have a time and a place. So I wanted to, again, bring this to the surface here and help put more squarely on the radar screen, what this is and when you may want to consider using it.

Dr Ruscio, DC:

The backstory on this compound: it was prescription-only for a while as a formula known as EnteraGam—a medical food, a powder, prescription only. And I remember during my nightly PubMed couch-reading, I’d see a study on this and say, “Hmm, interesting.” I’d click through. “Prescription only.” Is it worth the rigor of trying to figure out how to integrate this into the clinic with so many patients being telehealth and prescription across state lines being challenging? Yeah, not yet. So I put it aside. A few months later, [I] see another study. “Hm, here that is again, gosh, this is looking compelling. This is looking interesting.”

Dr Ruscio, DC:

And after maybe a year of that and having my curiosity continued to be stoked, it became available non-prescription (over-the-counter). And when that happened, I said, “okay, I now want to bring this into the clinic.” And first, I want to do a deep dive to make sure it has efficacy (it’s effective) [and] safety (it’s not going to harm people), of course. And once we cleared that bar, I brought it in the clinic and I said, “okay, let me set this up in an isolated experiment with our patients so I can really get a signal for [if it works].” Because if someone comes in and you have them do curcumin and fish oil and gluten-free and probiotics AND this, sure, I’m positive people are going to come back and say, “I feel better.” But that doesn’t really help me tease out [if] this produce[s] enough of a clinical signal to make it worthwhile to use.

Dr Ruscio, DC:

Because that’s the other thing, is the effect size. And you will see the effect size reported in the studies. And so you do get an indication from the research, but clinicians also have to apply it in their model. And what do I mean by that? Well, if most of the research, let’s say, is occurring in conventional gastroenterology clinics and maybe they’re trying this in patients who haven’t done a bunch of the stuff that we would recommend, well, when we try it, we may say, “helped a little bit, but not really worth it” because of the context for which our patient population is in. So when doing the experimentation in the clinic, the signal was clear.

Dr Ruscio, DC:

[Of] the first six patients, five of six had a notable response—given (very important context) that this was people who had established what diet was best for them, lifestyle practices [were] fairly well in place, probiotic triple therapy onboard, some degree of elemental dieting, and some degree—in many cases—of use of antimicrobial or antibiotic therapy. And then we’re still getting a signal in patients who had some residual symptoms or recalcitrance. So I said, “okay, this is a product that we’ve really got to start using. We should be codifying into the clinical model.”

Dr Ruscio, DC:

And [the clinic] did an even deeper research dive to make sure as we brought this to the broader audience, we could give them some recommendations on the different forms (there’s really two forms: there is the animal-derived and then there’s also a vegan, which is derived from egg), and dosing, and all the important things that if you were going to introduce this in a nonclinical setting (as a podcast and a product for people to use) we gave them the appropriate supports. And that’s what we have done. We have the animal-based formula as a pill or a powder. I would really recommend the powder because it’s much easier to dose and we’ll go overdosing in a second. And we also have the vegetarian version as a capsule.

Dr Ruscio, DC:

Okay. But let’s zoom out just a touch first. The best way, in my opinion, to use this is not early phase—for no other reason than there are therapies that are more tried and true (like diet, probiotics, elemental dieting) that should be used first.

Dr Ruscio, DC:

How do the immunoglobulins work? The way I like describing this, the simple version, is if you were swallowing shards of glass, those shards of glass would irritate your system, cause damage and inflammation. However, if we were to dip those shards of glass in wax, and let the wax cool, then you could swallow them and they would pass through without causing lacerations and damage. And this is essentially what am immunoglobulins do. They bind to toxins and to irritants, namely bacterial fragments—and I would also assume fungal fragments, although that hasn’t been formally demonstrated to my knowledge—and deactivate them, like dipping a shard of glass in wax. And by doing so, we really have a favorable impact on the immune system.

Dr Ruscio, DC:

And that is what is unique and novel about immunoglobulins. We’re hitting this from a more immune-system-centric perspective. And remember, the rough model that we’ve used to describe this is: you need to have a healthy microbiota and a healthy immune system to really have optimal gut health. And many therapies, yes, will act on both but there’s probably a lean in the direction toward the microbiota, whereas this compound has more of a lean in deantigenizing, if you will, or deactivating toxins and irritants—thus stopping the immune system response, stopping the result in inflammation and damage that occurs from that, and to some extent the no nociception or the pain. Because remember that inflammation actually makes one more sensitive to this pain-signaling molecule called substance P. Okay, so what evidence do you have? Right. Stop telling me the story of why this should work so well. Show me the evidence that this actually does work so well.

Dr Ruscio, DC:

This is where it gets even more exciting. There have been roughly 10 studies looking at this, ranging from design from K series to randomized clinical trials. And let’s go through a few of them. One of these pilot studies gave either 5 grams or 10 grams per day, and they a significant improvement in both gastrointestinal symptoms and daily symptom scores in those who had IBS. So pretty timely or relevant for our audience. And another study in the “Open Journal of Gastroenterology”, and this is key, found that 10 grams per day was helpful in drug-refractory—meaning a conventional gastroenterologist had used things like Refaximin, Antispasmodics, what have you, and none of the drugs worked—there was responsiveness in this patient cohort, which I think is really important to clarify, that even in patients who haven’t responded to other therapies, we’re seeing response.

Dr Ruscio, DC:

Another trial published in “The World Journal of Gastroenterology” made the following comment that, “in most cases, the therapeutic effect of SBI was seen within the first four weeks of therapy with continued improvement at their subsequent visits.” And that the immunoglobulins had, “multifaceted mechanism of actions and may help to manage IBS by providing a distinct protein source required to normalize bowel function, gastrointestinal microbiota, and nutritionally enhance tight-junction (or leaky gut) protein expression between epithelial cells. This medical food provides a safe option for patients with IBS and may have other applications in other forms of IBS.” So that’s pretty interesting and pretty exciting.

Dr Ruscio, DC:

And another study found that the microbiota, at least the beta diversity, became healthier after use. That’s a few trials.

Sponsor:

Hey, everyone. We’ve had a number of people reach out and ask how to refer someone to our clinic. And to make this easy, we created a page: DrRuscio.com/referrals. And our office is happy to provide a referral source for challenging patients or clients. Working with people in a clinical setting is really at the core of what we do. So again, happy to help however we can. Simply enter the person’s contact information and our office will take care of the rest. This probably goes without saying, but you can rest assured that the client or patient that you are referring will obtain progressive yet cautious care, care that is cost-effective. We will not order unnecessary lab work. We will not use copious amounts of supplements. Also, our care is devoid of overzealousness and fear-mongering. And we use treatments that are science-based and cause-focused. That URL again is DrRuscio.com/referrals. And, again, more than happy to help however we can.

Dr Ruscio, DC:

The one that I think is the most compelling was by Leonard Weinstock, who’s been on the podcast before. And shout out to Leonard. And in this case, patients were diagnosed with either SIBO, IBS, or both, then offered a few different treatments. In those who did not respond to any treatment, they were given immunoglobulins. And they noted a 75% response rate. Now, this is not placebo-controlled. So that response rate should maybe be cut in about half because placebo probably accounted for some of that. But nevertheless, we’re seeing in a functional gastroenterology clinic— who’s not just going to do the run-of-the-mill conventional GI work, this is Leonard Weinstock, [who is] fairly knowledgeable in both conventional and alternative GI therapies, and even in this patient cohort with all those tools to bring to bear—a 75 (albeit not controlled) response rate was noted.

Dr Ruscio, DC:

And this is similar to what I did in my clinic, where I wanted to not make this the first thing that we did. And I’m thinking, “okay, this is a tool we can add in.” So I’m not going to use it first. I’m going to use it in this recalcitrant, non-responsive population. And I saw a clear benefit. And we do have a placebo-control trial to cross-reference here. So we check that box also. But [I’m] just trying to articulate that in those who have been non-responsive, this therapy has shown benefit. And, by the way, if you want to see all of these references, you’ll see them on the product age, but they’re all there. Because we try to make sure to give you as much science as possible. And you will see the double-blinded randomized control trials that we’ve linked to there, if you want to be the most persnickety in how you’re evaluating this, as you should be.

Dr Ruscio, DC:

I also sent some of this to my good friend and colleague, Dr. Allison Siebecker, and it helped prevent, food poisoning associated with travel. And I’m just double-checking her note here. And we actually put this up on the product page because this was a really compelling case study. She said, “my husband and I both tried it at 4-8 capsules per day, and here’s what we noticed: it improved our complexions, stopped us from getting colds.” They had started it that day and within 4-6 hours weren’t sick anymore and [it] prevented the food poisoning in Mexico that a person in their party got, even though they shared the same lunch. So some suggestion that this may help with Traveler’s diarrhea. And she suspects it also helped with her bloating and expanding her food tolerances.

Dr Ruscio, DC:

Additionally, it lowered her cholesterol, which is genetically high into the normative range. And there are a couple trials that have also documented that. And I actually had missed that in my review of the evidence, probably because I wasn’t looking for immunoglobulin’s impact on cholesterol specifically. But when she mentioned that I said, “Hmm,” went into PubMed, and there are trials showing that. And this should not surprise people, given the fact that it binds. And things that bind likely also bind bile. And bile sequestrants help detoxify (perhaps why her skin looked better) but also help to lower cholesterol, because when you bind bile and essentially poop it out, your body has to make more cholesterol and more bile, and making more bile utilizes cholesterol.

Dr Ruscio, DC:

So a cool anecdote from Allison. And [it] actually opens up the door for a couple of applications (one of which is evidence-based), the cholesterol-lowering, (one of which is anecdotal) the potential ability to reduce or mitigate Traveler’s diarrhea. And remember, from a gut perspective, the immunoglobulins as Intestinal Support Formula are likely helping because when you intervene and stop this cascade, you see a degree of healing. And the cascade is really this immune activation and inflammation, this damages the lining of the gut, that leads to further leakiness and therefore immune activation, and then further propagates leaky gut. So there’s this downward spiral. And if we can intervene, we can turn that, hopefully, into an upward spiral.

Dr Ruscio, DC:

And one other data point here is that—and this is also linked in the product page—that one study found improvement in markers of nutrient absorption when using Intestinal Support Formula, which would make sense. If we’re doing what we’re claiming to do with this compound, in that we’re reducing inflammation and reducing gut damage and leaky gut, we should see markers of improved absorption occur also.

Dr Ruscio, DC:

So a really interesting compound in the sense that you can detoxify and get rid of some stuff, but better absorb other things like nutrients, as you want to. And this is really what happens when you have a healthy gut membrane, right? It shouldn’t be surprising that you’re less toxic and you are more nutrient-absorbing when you have a healthy gut. [This is] part of the reason why gut health is just, of course, so crucially important.

Dr Ruscio, DC:

Now, what about the dose? Five grams per day has been used in some trials and has shown to be effective. 10 grams has been used in more trials and shown to be effective. Where do I come down on this?

Dr Ruscio, DC:

Well, as you know, I am a minimalist. And I think the minimal effective dose is usually the best. And I would start with five grams. I would say five grams should suffice for most. However, there have been a few clear cases where patients start at five, saw nothing, and then, per our conversation, they knew that 10 grams was an alternative dose option and only saw and did see a notable response when going up to 10. Now this matters because double the dose is double the stuff to swallow and double the cost. So we want to be prudent here.

Dr Ruscio, DC:

So what I’d recommend is as follows: one study tracked symptomatic response, quantified via a Likert score, week over week, and you see the symptoms really start to move around two weeks. (The other study concluded by four weeks but if you look at the week over week Likert score analysis, you’re seeing the needle move at two weeks.) So I’ll tell patients that around the second or third week, that’s our first benchmark. This is helping, yes or no. Not this is fully resolved my problems, yes or no. But this is helping yes or no.

Dr Ruscio, DC:

So that’s your first reevaluation period, two to three weeks in. Now, if you’re responding, great, continue, don’t change anything. People tend to level out with their level of improvement between week 8-10 or week 8-12. Somewhere around the two to three-month mark people tend to see a plateauing in their improvements. So you want to continue through, if you do hit benchmark one (improvement), continue through and then reevaluate, reappraise your plateau at month 2/month three. If you’re not seeing any benefit at the 2-3 week mark, go up to the 10 grams per day and run the experiment again for another 2-3 weeks.

Dr Ruscio, DC:

By the way, normal disclaimers always apply. This is the theoretical application. You must check this with your doctor. But this is just taken from some of the research and how we want to educate on how to use this compound at the discretion of your clinician. And then reevaluate after the 10 grams per day, benchmark point 2-3 weeks plateau point 2-3 months. And once you’ve hit the plateau, there’s no set rule in terms of, “well now that I know I’ve plateaued and I’ve been plateaued for a month, I’ve got to go down.” However, I think the most prudent way to approach this is once you’ve hit a peak of improvement or a plateau, and you’ve been stable there for at least a month, then start to wean yourself off.

Dr Ruscio, DC:

This is not something that one should need long-term and ongoing. I want to be very careful in disclosing that because I want to try to prevent the drift into supplement dependence. So I don’t think this is something you need to be on long term. Probiotics, I think you can make a different case. Not Intestinal Support Formula. So go through the ween-off exercise, come off and what you should see is that you don’t need this long term. And I would really encourage you to try to frame this as such. This is something that can give you a cycling of decreasing the inflammatory immune wind up, allow some healing, and once you’re healed, you don’t need this. Don’t make it a crutch.

Dr Ruscio, DC:

Now, sure, in select cases, people may need this for a longer course, but we want to go in with the expectation of this almost as an immune reset, if you will, and not, “well, this is one more thing I’m taking forever.” Because if we don’t clarify that, that’s where people tend to end up. And ween yourself off and great, now you experimented with this therapeutic, you’ve learned how to use it, how it can help you, what the response feels like, and you can always pull this out again at a later date. And repeat a cycle on this.

Dr Ruscio, DC:

And that’s pretty much it. Those are the main things I wanted to go through. There is an interesting case study…I’ll put it in the description of the podcast and also in the notes for the show, but it’s essentially pretty easy to find if you search “Gut Healing Often Involves Ups and Downs: Matt’s Story with Inflammatory Bowel Disease.” We detail how in Matt’s case, just like I was outlining, he had responded to diet, to probiotics, very well to antimicrobials, and, “yay,” we were at the point where his life was normalized and he was no longer crippled by needing to be near the bathroom due to the frequent bowels of his inflammatory bowel disease. I think it was ulcerative colitis, specifically. I might be wrong on that.

Dr Ruscio, DC:

And he was really discouraged to, a few months later, have a relapse. We tried antimicrobials again. Didn’t move the needle. [He] was even more disappointed, “Oh man, this therapy that helped me so much before isn’t moving the needle again, what do I do?” And the immunoglobulins for him was a home run. And I believe there’s also a few trials published with immunoglobulins for inflammatory bowel disease (I might be wrong on that detail, I’d have to double-check.) But I’m somewhat confident that these have been shown helpful also in inflammatory bowel disease, as it was in Matt’s case.

Sponsor:

Hi, everyone. If you are in need of help, we have a number of resources for you. “Healthy Gut, Healthy You”, my book and your complete self-help guide to healing your gut. If you’re not a do-it-yourselfer there is the clinic—the Ruscio Institute for Functional Health—and our growing clinical and supporting research team will be happy to help you. We do offer monthly support calls for our patients where I answer questions and help them along their path, health coaching support calls every other week, and also we offer health coaching independent of the clinic for those perhaps reading the book and/or looking for guidance with diet, supplementation, etc. There’s also the store that has our Elemental Diet line, our probiotics, and other gut health and health-supportive supplements. And for clinicians, there is our FFHR—the Future of Functional Health Review—database which contains case studies from our clinic, research reviews, and practice guidelines. Visit DrRuscio.com/resources to learn more.

Dr Ruscio, DC:

Here’s one aside that irritates me. There is an ad, as I went to double-check this video and what the title was to give it to you here, an ad pops up for a direct-to-consumer stool test, which has a goose egg of validation. 0, 0, 0 validation. So this just shows you what we’re contending with. Trying to get people good evidence-based guidelines for improving their gut health. We’re going through all these therapies that can help you, the best sequence to use them in, and, I like to think, carefully evaluating some of the science and helping you understand the merits and limitations and usage guidelines for a therapy.

Dr Ruscio, DC:

And as I’m trying to navigate to one of these videos, this company has bought ad space before my video will play to, in my opinion, spam you with marketing from a guru—if you see the ad you’ll know who I’m talking about—from a health guru, who by the way, has been heavily chastised by the scientific community for kind of bastardizing certain claims in the health space. But nevertheless, a fairly big name, promoting a stool test that proclaims to tell you everything you need to know about your health with zero validation data. Similar to Ubiome.

Dr Ruscio, DC:

So anyway, sorry for the aside there, but I just think it’s important to give some context in terms of health is marketable and not all those who are marketing you a product or service have done the same level of due diligence. And they probably believe in their product.

Dr Ruscio, DC:

And this is one of the things that I think makes it the most challenging, which is this willful ignorance or misguided benevolence, where people are trying to help, they just don’t understand that they haven’t evaluated science correctly and are giving you poor recommendations. And even though they want to help you, they don’t realize that they’re actually likely going to harm you.

Dr Ruscio, DC:

And UBiome, I think, is a good example of that. I’m assuming the people at the company were mostly people who were trying to do well. I say mostly because someone there knew, obviously, that they were putting dog poop into the data to figure out what the normative ranges were for humans. So some people there knew what was going on, but I’m assuming the majority probably thought that they were really helping people.

Dr Ruscio, DC:

And to be totally fair, some of the people who got a uBiome back—as inaccurate and fraudulent as that test was—probably made some healthy changes because of that. So fine, fair, whatever. But when people spend, depending on, I think they had different levels of offerings and if you do more than one test, you could spend hundreds to several hundred dollars. And for what you didn’t need to spend any of that money on. And then at the other end of the spectrum, the people who really glom on to the findings and feel like they’re sick. If you remember Danielle’s case study, the doctor based upon a stool test said, “you’re really sick, you got to start taking your health seriously,” for a person who was so OCD about their health, that she needed to do the very opposite and relax about her health, is where I take such issue with these tests.

Dr Ruscio, DC:

So anyway, another issue. But coming back to immunoglobulins, those are some guidelines for dosage usage, what the evidence shows, when and how to use them, not a panacea, inflammatory reset, can help heal your gut. And again, [I] just wanted to surface this because we haven’t discussed it in a while and it is something that we use at the clinic. And it just hit me the other day that I should probably take a moment and discuss this tool because it does have a time and a place. There is the requisite scientific evidence. And I satisfied my inquiry about effectiveness in the clinic in an isolated fashion, and that supported what the evidence shows.

Dr Ruscio, DC:

And so here’s one more tool to have in your kit to use periodically to really support your gut, more so from the immune-inflammatory side of things. And you might see some side benefits like detoxification, lowering of cholesterol, and improve nutrient absorption on top of the foundational benefit of reducing inflammation, reducing the immune response, reducing leaky gut, allowing some gut healing, and allowing improved food tolerance (as Allison’s case illustrated).

Dr Ruscio, DC:

And we do have another video case study of another individual who reported much better histamine intolerance. And really it shouldn’t be a surprise that as you improve the health of your gut, you have better food tolerance. Okay. So that is the, I guess, long of the long and short on am immunoglobulins as our product Intestinal Support Formula. If you’ve tried it and it helped, try it again if you’re in need. Hopefully, you’re not. And if you haven’t tried it, consider it. And now, hopefully, you have the guidelines to do that experiment confidently. Alright guys, hope that helps. And I will talk to you next time.

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