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Helping Families Navigate Pediatric IBS-C Treatment

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Pediatric irritable bowel syndrome with constipation (IBS-C) can significantly affect quality of life and presents unique treatment and counseling challenges for patients and families. This course reviews evolving management strategies for pediatric IBS-C, including newly approved treatment options and practical considerations for therapy selection. You will be better prepared to evaluate treatment approaches and counsel families on the safe and appropriate use of therapy for pediatric IBS-C.

HOST
Rachel Maynard, PharmD
GameChangers Podcast Host and Lead, Clinical & Partnership Education, CEimpact

GUEST
Christopher Hartley, PharmD, BCPPS
Pediatric Clinical Pharmacy Specialist,
The Johns Hopkins Hospital 

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 CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Describe current treatment considerations for pediatric IBS-C, including recently approved pharmacologic options.
2. Compare factors that influence treatment selection and family counseling for pediatric IBS-C.

Rachel Maynard and Christopher Hartley have no relevant financial relationships to disclose.

0.075 CEU/0.75 Hr
UAN: 0107-0000-26-300-H01-P
Initial release date: 8/3/2026
Expiration date: 8/3/2029
Additional CPE details can be found here.

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Welcome And How To Earn CE

SPEAKER_00

Here on Game Changers, we're all about helping you stay ahead of pharmacy practice. But why stop at listening? You can earn CE credit for this episode and hundreds more by visiting CEimpact.com and logging into your account or creating a new one. Get credit, get inspired, and make your learning count. Hey CE Impact subscribers. Welcome to the Game Changers Clinical Update Podcast. I'm your host, Rachel Maynard. Today we'll be talking about the management of irritable bowel syndrome of constipation, or IBSC, specifically in pediatric patients. This is coming up now because the FDA recently approved the first treatment for IBSC in pediatric patients, which is lenoclotide. And this will raise questions about IBSC more broadly in pediatric patients and where this newer option fits in. So we have a pediatric clinical pharmacy specialist to help answer those questions, and I'm very thrilled to welcome Dr. Christopher Hartley. So welcome, Christopher.

SPEAKER_01

Awesome. Thank you so much for having me. So my name is Christopher Hartley, and I am a pediatric clinical pharmacy specialist at the Johns Hopkins Hospital. I cover the pediatric uh surgery, gastroenterology, hepatology, and nutrition team here at the Johns Hopkins Hospital. And then I'm a clinical adjunct professor at the University of Rhode Island, as well as a part-time assistant professor of the Department of Surgery here at the Johns Hopkins School of Medicine. Thanks so much for having me today.

SPEAKER_00

Yeah, we're very excited to have you. And I know given your expertise here, it sounds like you're a great fit to speak about this option and where it might fit in for managing IBSC and pediatric patients. So I think this is a question that tends to come up just because um constipation can be common in children and and it's often maybe difficult to manage. And so thinking about what options are available and helping sort through all that is going to be really helpful, I think. So very excited to have you and thank you for your time. But let's start with just an overview of what IBSC is and how it differs from other forms of constipation.

SPEAKER_01

Yeah,

IBS-C Vs Organic Disease

SPEAKER_01

sure thing. So IBS, the first thing I think that we should think about is looking at our um NASP again, the North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition. They first define as looking at organic causes of disease versus functional causes of disease. So your organic causes of disease are going to be things that are proven or have a physical cause. So that would be like structural damage, inflammation, biochemical abnormalities. So this is going to be things such as your GERD, ulcers, your Crohn's disease, or your ulcerative colitis, celiac disease, or colon cancer. And then there's going to be your functional diseases. And so functional diseases are different in the fact that they have a structurally normal anatomy that doesn't function well. And so for these patients, the biggest thing is going to be that generally for parents, there's going to be a lot of questions. There's going to be a lot of tests, and those tests are generally going to be inconclusive. And so, you know, they might get an X-ray, they might get a CT scan that won't show anything, but functionally they're having a lot of issues. And so that's where our, you know, IBS and would come in compared to our IBD or irritable bowel disease, like ulcerative colitis or Crohn's, where they would actually have structural abnormalities along their cells and inflammation.

SPEAKER_00

Right. Okay. So that's a good clarification. So inflammatory bowel disease is an example of more of that physical uh sort of cause, whereas this organic ideology could be hard to pinpoint, really hard to define what exactly might be leading to IBSC, then is what you're saying.

SPEAKER_01

Yeah, exactly. And so it's it's a symptom-based, right? It's a diagnosis of exclusion almost. And so historically, uh, as early as the 1950s, this was first described by uh John Appley as having episodes of abdominal pain severe enough to affect activities with greater than three months. And so these patients are going to have abdominal pain, which is somewhat where it's differing from functional constipation. Um, but they're not going to actually have if you went under for like a colonoscopy, they wouldn't actually show those signs of disease.

SPEAKER_00

Okay. So you mentioned uh the constipation and the abdominal pain, and you highlighted a little bit about that frequency, but could you tell tell us a little bit more about that and and what is considered IBS C versus just sporadic constipation and possibly abdominal pain to go along with that?

SPEAKER_01

Yeah, sure thing. So for the abdominal pain aspect, so essentially for IBS C, there's two different thoughts of how it occurs. So there's a top-down approach, which is where the it's a brain gut connection for a lot of functional diseases, is how it's described. And so that brain gut connection, the top-down approach would be that the brain is sending impulses to your peripheral organs on a brain gut axis that generally generally creates uh alterations in your body that causes either that constipation or that diarrhea. And then there's also a bottom-up approach, which would be that peripheral factors in the gut are leading to um changes in your cerebral function that causes some of this. And so a lot of the time, the kind of big challenge is figuring out what exactly does this patient have.

SPEAKER_00

Right.

SPEAKER_01

And so there's a lot of different things. And so

Rome Criteria And Bristol Stool Scale

SPEAKER_01

um the Rome criteria, which is the big um, you know, non-for-profit organization that does a lot of these diagnoses of um functional brain gut connection, has a couple of different uh subcategories for different types of bowel disorders. So, for example, you have your IBS C, and so IBS can be further subdivided, IBS can be primarily constipation-based, primarily diarrhea-based, or a mixed picture. And so that has to do with the abdominal pain that occurs from this um disease plus the Bristol stool scale, which is a scale of one through seven for how hard or how soft your bowel movements are.

SPEAKER_02

Okay.

SPEAKER_01

And so one would be similar to like acorn. Three is like kind of sausage, kind of around where you want to be is a three to four. And then seven would be um liquid diarrhea.

SPEAKER_00

Okay.

SPEAKER_01

And so for patients, if you have the majority of your stool being that uh one and two on the Bristol scale, that would be a IBS C or constipation. Whereas for the diarrhea, it would be more towards a Bristol of six or seven.

SPEAKER_00

Okay.

SPEAKER_01

And so the IBS is one of the subcategories, then there's functional constipation below that. Functional constipation would be that you could still have these Bristol stools of one to two, but the big difference is that they don't actually experience pain with it.

SPEAKER_00

Okay.

SPEAKER_01

So in when we get into some of the studies for this medication, they do study both functional constipation and IBSC at the same time, which is somewhat interesting. And then other ones that are similar kind of brain-gut disorders are going to be opioid-induced constipation, technically falls under Rome criteria now, functional defecation disorders, and then functional abdominal bloating or distension.

SPEAKER_00

Okay. Okay, so that's a good differentiator. So thinking about IBSC specifically, it can be this mixed picture, as you said, or primarily with constipation or diarrhea, and thinking about the abdominal pain that goes along with either the constipation or diarrhea, that's a key differentiator, it sounds like. And in terms of frequency, how often are patients with IBSC considered, how often can we expect them to be reporting abdominal pain in addition to that constipation?

SPEAKER_01

Yeah. So generally they would be having um, it's usually less than three abdominal movements per week over a three-month period. Yep. Bowel movements. Bowel movements. Okay. Yep. And so generally the pain is associated when you are having that bowel movement as well.

SPEAKER_00

Okay. Okay, got it.

SPEAKER_01

And it should spine, it should clear with that bowel movement.

SPEAKER_00

Okay. And so, in terms of pediatric patients specifically, because that's that's sort of what's new in why we were talking about this, is because this linaclotide is uh now approved for pediatric patients. Are are do they present any differently than adults? Or can you talk a little bit about how common IBS C is in pediatric patients? How much how often do we see this?

SPEAKER_01

Sure, yeah.

How Kids Present And What To Ask

SPEAKER_01

So um, generally speaking, for um pediatric gastroenterologists, this is one of the most common reasons why these patients would present to clinic. So IBS C specifically, IBS C is much more uh common in children, whereas for adults, you have more IBS mixed picture or IBS diarrhea. And so that's kind of where the big differentiation is.

SPEAKER_00

Interesting. Okay, so it's not uncommon. And it I guess if you were, if you had a patient presenting to you, regardless of your practice setting, and the patient was complaining of constipation with uh abdominal pain, what sort of next steps would you what are the you said it's a a clinical diagnosis rather than necessarily something or a diagnosis of exclusion. And so what are sort of the next steps if you have somebody presenting with these symptoms, what kinds of questions would you want to ask?

SPEAKER_01

Yeah, sure. So a lot of the questions that you're going to be asking these patients, first off, you're going to want to make sure that you're ruling out things such as you know, an IBD picture, so Crohn's oral cervicalitis. So, in order to do that, you generally, these patients, when they come in with abdominal pain, depending on the age that you're looking at, you might be having to roll out things like appendicitis. So they might be getting an X-ray to look uh to see if their appendix is inflamed. Because if that's the case, then you can, you know, go in and do an appendectomy. And then if they are quite backed up, so if they need a like a pharmacologic disimpaction, so using something like uh polyethylene glycol to clean the patient out, generally that's part of the story as well. And then also getting a good med history on the patient. And so for these patients, if you have long-term constipation, what can actually happen is you can actually have a fecal ball form in the rectal vault. And so if that happens, because in your large intestine, the primary thing that's happening is you're pulling a lot of your water out of your stool to reabsorb it. And so the stool itself can actually calcify. And if the stool is calcified enough, that would be where you might need a manual disimpaction in order to clean that out. But you want to make sure also these patients could, in their description, tell you that they are having some stool that's wet stool that they're not able to hold in, which would be called encoperesis. And so that's actually where the uh liquid stool is going around the outside of that calcified stool ball and coming out. And so that could uh ruin clothing for them and make it harder for them uh because they wouldn't be able to control that.

SPEAKER_00

Okay, got it. Okay. Yeah, interesting um considerations there to be listening for. And as you say, to also take that med history, find out how long this has been going on, think about um medications that might be contributing to constipation more broadly. And I think also, you know, thinking about red flag symptoms like bleeding, weight loss, that sort of thing. But yeah, in terms of the management of IBSC, if you have somebody who is his diagnosed, what what are the standards and in pediatrics specifically we'll focus on, but what are the standard treatment options for this?

SPEAKER_01

Yeah. So your

Standard Treatments Plus Non-Drug Tools

SPEAKER_01

most common uh treatment options, none of it was actually studied in in pediatrics, interestingly. Um, but generally speaking, it's your high-dose stimulant laxatives. So that's gonna be like your sides and your bisycodal. And so this is going to help with kind of that intestinal smooth muscle squeezing, right? Your push to try to squeeze out the uh stool, as well as um using like your polyethylene glycol, so your osmotic agents. Those are kind of your main stays of therapy. You're going to be giving high doses and you're going to be trying to get them to have that come out. You could use stool softener, so that would be like your docucate, but doesn't help as much as your high dose stimulant laxatives. And then with the pain aspect, this is where you use like your anti-spasmodics. So things like uh dichlamine and hyocyamine are your two most common. And those are going to be blocking acetylcholine.

SPEAKER_00

Mm-hmm. Mm-hmm. And what about in children specifically? And knowing that this is a chronic condition and these medications may need to be used longer term. What are the considerations around that? What kinds of discussions do you have with parents around safety considerations?

SPEAKER_01

Yeah, definitely. And so in that area as well, you also want to make sure that you're trying to think of, you know, what's the long-term aspects for this and what kind of other things can you do that are besides medications, right? Medications work great, but this is going to be things like guided meditation, yoga therapy. And then if they have specifically defecation issues, you can actually go to um pelvic floor therapy for this. So primarily pelvic fluorotherapy, you're thinking of patients um after giving birth. Um, but there are physical therapists that actually do pelvic floor therapy for patients that help when they have IBS, which is kind of interesting to help with making sure. And I think that that's kind of also where some of the things like um squatty potty come into play.

SPEAKER_00

Uh-huh. Uh-huh.

SPEAKER_01

Uh, and so making sure that you have a good um setup when you're actually using the bathroom to make sure that you're on there, but also making sure that you're going frequently. So the general recommendation is that after you eat your food, you should go to the bathroom about 30 minutes later, and you should spend no more than 10 to 15 minutes on the toilet itself.

SPEAKER_02

Mm-hmm. Okay.

SPEAKER_01

Uh, and then there is some controversial opinions on diet. So this would be like your FODMAP elimination diet. And so this is FODMAP is fermentable oligosaccharide, disaccharides, monosaccharides, and polyioles or short chain sugars that can lead to cramping, diarrhea, constipation, stomach bloating, gas, and flatulence. So these foods, it's generally, if they're going to do this, they would do it for two to six weeks to see if it has any benefit, but not long term. And so this would be things like dairy-based milk, yogurt, ice cream, wheat-based products, beans and lentils, artichokes, asparagus, onions, apples, cherries, pears, and peaches. So kind of all your things that you think of that are really tasty, in my opinion. Um, you kind of get rid of those, and then you you see if that helps. Um, it's controversial because it's a lot of things out of your diet. Right. And a lot of those things are kids things that especially uh a kid would really enjoy, right?

SPEAKER_00

Right, right. You know, you're kind of taking out a lot of nutrition. Yeah, you're trying to provide nutrition too. They're growing. So yeah, that's a challenge.

SPEAKER_01

Yeah. And so that's uh one of the biggest things I think that's challenging is that you have to figure out, you know, how much buy-in can you get and how much of this kind of uh cognitive behavioral therapy aspect can you do while you're also giving these medications to hopefully set this kid up for success.

SPEAKER_00

Right. Right. Yeah. And and that I just like with most things in pharmacy, the the non-drug measures are almost as important, if not more important than the drug measures. But um it is good to know that there are options to try, both non-pharmacologic and pharmacologic. And I think you highlighted a few of those, those treatment options that are sort of current standard of care. And so if we think about, you alluded to the fact that a lot of the the data we have for these treatments are based on uh adult, uh adult treatment success. And so when we think about this newly recently approved linoclotide for IBSC and pediatrics, what kind of data do we have to support the use of this option? Because it made a little bit of a buzz. And how does it fit in when we think about those other options you described?

SPEAKER_01

Sure.

Linaclotide Mechanism And Pediatric Data

SPEAKER_01

Yeah. So one of the things um that I think is always, you know, interesting is we have, you know, FDA approvals and then we have a lot of, you know, these smaller kind of case studies. And so in pediatric literature, a lot of the times you really don't get a great clinical trial that's happening, right? You whereas for adults, you could get, you know, several thousand patients for pediatrics. Usually um it it starts out with a smaller group that's trying something and they present a case report somewhere or a case series, or they have a poster at one of the, you know, conferences, and then kind of everybody tries it out from there. So it's not infrequent that um we have these, you know, adult studies where you have this a big adult study, and then you have this much smaller pediatric, you know, study that might be single center. Maybe you have a couple of colleagues at other institutions that are also interested in this and want to try it out. And they're also, you know, trying to see. I think, you know, in pediatric studies, it's always challenging because you know, they're a vulnerable population. And so when you're looking at your IRB for these patients, for patients that are pediatrics, uh, older adults, incarcerated individuals, those patients are always going to be harder because they can't advocate for themselves the same way. And so a lot more of that, you know, safety information has to be done before they're able to actually try a clinical trial. But linaclutide is kind of cool because they actually have some pediatric data, which is great. The other medication, just before we talk about that, uh, that was previously on the market before linaclotide was Lubiprostone. And so this was a medication that was had some randomized control trial in pediatrics. And it's similar to linoclotide uh in that it's a secret sec secret, it's a secreting uh medication. And so with that, um, what it's doing is it's pulling intracellularly into the GI tract to help with those bowel movements. This medication actually ended up not being used that often because in some of the pediatric or randomized controlled trials, it actually had no statistical significance uh for spontaneous bowel movements when compared to placebo.

SPEAKER_00

Okay.

SPEAKER_01

So then linaclotide comes onto the market.

SPEAKER_00

Yep.

SPEAKER_01

And so it's a guanylene cyclase C receptor agonist. So what it's doing is it's increasing intestinal fluid secretion, accelerating intestinal transit, and decreasing visceral pain. And so the first study for this was a phase two clinical trial, and it was done by Carlo DiLorenzo and colleagues. And this one is on clinicaltrials.gov, which is a great place to look for a lot of these studies, especially if they don't actually have the you know paper out yet. Uh and so this was a phase two clinical trial that was safety and efficacy of linoclotide in children seven to 17 with IBSC. So this was a safety and an efficacy study. It was four weeks, randomized, double blind, placebo-controlled, parallel groups. And this one was kind of interesting because it was a dose-ranging trial. So normally, if you're thinking about your you know, clinical trials overall, generally your phase one clinical trial is going to be where you're trying to figure out, you know, the dosing. Phase two is where you're figuring out the safety of it, and some of the efficacy, phase three is kind of your big trial where you're looking at efficacy, and then you get your post-marketing data. And so this one was interesting in the fact that it does dose ranging. So they took patients and they figured out their dose. They had three different categories in all of their doses, and so they had one group that was 18 to 35 kilograms. They had one, and then they had greater than 35 kilograms. And so within those, they would give a a fourth of the dose, a half of the dose, or what they wanted to do as like their actual dose to see if there was any difference in abdominal pain or side effects.

SPEAKER_00

Okay.

SPEAKER_01

And so this one, the primary endpoint, was change in baseline during a four-week period in spontaneous bowel movements. And spontaneous bowel movement is described in all these studies as a the having a bowel movement where you didn't have a laxative or a suppository or an enema that day or the day before.

SPEAKER_00

Okay.

SPEAKER_01

And so for this study, it's kind of interesting. So for the PDA, the actual uh FDA approval now, looking, you know, a couple of years later, the dose is 145 micrograms once daily. Um, but in this, for patients that were 18 to 35 kilos, they started as low as 18 micrograms. So a much lower dose, and they went as high as 72 micrograms. And then if they were greater than or equal to 35 kilos, then they got anywhere from 36 micrograms to 145 micrograms. So actually getting up to that dose that you're going to do for your approval. Their secondary endpoints was uh change in bowel function, uh change from baseline in abdominal pain. And so they did one through four. And then the big part of it was their safety endpoints. And so They had 101 randomized patients that all tolerated the treatment well. They had treatment emergent adverse effects, which means that they had an adverse effect that they could specifically tie to the medication that was not there prior to the medication. And upon discontinuation, the side effect resolved. That occurred in 27 patients. So around 20 a fourth of the patients. Two of them led to treatment discontinuation, so abdominal pain or diarrhea. And the most common side effects were diarrhea and abdominal pain. All the diarrhea in the study was considered mild and none of it was severe, which is pretty similar to the adult data. And so this was pretty pretty good. Yeah. I mean, pretty good. It's similar to the adult data. It's lower doses overall than you would see in a lot of these patients when you're starting with IBS C. So IBSC, the starting dose for patient seven and up now is 145 micrograms, whereas functional constipation, your starting dose is 72 micrograms.

SPEAKER_00

Okay. Okay. And just to clarify, this drug was originally approved for previously approved for IBSC in adults, chronic idiopathic constipation in adults, and functional constipation in pediatric patients six and older. And now this new indication adds on to the IBSC in adult indication, expanding it to the seven plus population.

SPEAKER_01

Yep.

SPEAKER_00

Correct. Yep. Okay. And so it but what it sounds like is bottom line is there there is still more limited data, which as you said is sort of the nature of pediatric population data generally. And there's some we do have some data here from this dose ranging study. And I I guess where what's the bottom line from that that what you just described and what the approval is and where is its place in therapy for IBSC and pediatric patients?

SPEAKER_01

Yeah, sure. So

Dosing Choices And Place In Therapy

SPEAKER_01

actually before that, the there was a phase three clinical trial after from DiCarlo and colleagues. And so that's going to be the one in the Landsight Gastroenterology Hepatology from 2024, which is where that functional constipation uh approval comes from. And then there at Digestive Uh Diseases Week or DDW, which is a big conference, is where a lot of the data, especially like the kind of new stuff that hasn't actually been published yet, is where a lot of your data comes from for the IBS C patients. So more long-term studies. Um the one that was presented this past year at Digestive Diseases Week was a 52-week study, which is kind of interesting.

SPEAKER_00

Patients had to be much better than four weeks. Yeah.

SPEAKER_01

And so that's the other challenge with a lot of these studies. It's, you know, where, you know, where does it work in treatment? So this was um the digestive diseases week was 52 weeks, age seven to 17. Patients had to be 18 uh kilos or greater, which is pretty great. And it was patients from that phase three clinical trial with the functional constipation. They were either on 290 micro micrograms, which is the adult dose, 145 micrograms, or placebo from the previous trial. And then they were allowed to continue as an open label, which is interesting.

SPEAKER_02

Okay.

SPEAKER_01

And these patients uh still had diarrhea and abdominal pain, 6.1% of them had that diarrhea, still mild, none of them were severe. And so the place in therapy is kind of nice because it's a, you know, if you have a pediatric patient who is greater than seven years old and they, or you know, greater than that, 18 kilos, if they're six years old and 10 months and they weigh, you know, 20 kilos, you could probably still get away with doing it. You know, I think the biggest barrier there will be insurance that we'll talk about uh in a little bit. Um, but the place in therapy right now is if you have a patient who you've, you know, tried meditation therapy, you've tried cognitive behavioral therapy, you have been doing your gold standard, so that high-dose stimulant laxative plus your polyethylene glycol, and you're still not having, you know, full resolution of symptoms, they're still having that constipation and that abdominal pain. I think it's a great place to try. You know, if you usually I would start at, you know, that 145 micrograms, but it's very provider dependent. And so that's kind of the interesting thing. So I would say, you know, overall in IBSC, there's, you know, a lot of information, but not a ton of information. And so there, you know, some providers might start them at 72 micrograms, which is lower dose, more of a functional constipation picture. Whereas uh, and then you could always titrate up and some of them might start at 145 micrograms once daily. But I think it's a great thing to try. Um if you're thinking through like those big side effects, so diarrhea and abdominal pain, you know, some people will have that diarrhea uh pretty significantly. Um, it's considered mild in the study, but I feel like when patients are having that, especially if it's causing issues at school, right? Um, that might be enough to scare them to, you know, say, I don't want to try that again.

SPEAKER_02

Right.

SPEAKER_01

Um, the diarrhea does go away after about a week or so, which is good. And so one of the big points that I like to, you know, talk about is try it on a weekend, try it on a long weekend, maybe, yeah, just to make sure. But I think that it's definitely worth a try, especially, you know. I mean, some of these early studies, the safety and efficacy study was a four-week trial. So you could always try it. And if it's not helping you out, you could always, you know, get rid of it. And I think that that's an important aspect of our job as pharmacists is, you know, helping with that prescribing information, but also helping with deprescribing if we need to, and if we're not seeing a benefit.

SPEAKER_00

And to that point, would a patient add this, be adding this to those laxative and um potentially antispasmodic options as well? Or is this a replacement?

SPEAKER_01

Yeah. So according to the like NASPEGIN group, which is the North American Society, their committee guidelines were should be considered as adjunct to high-dose stimulant laxatives when treating refractory constipation with poor response to optimize high-dose stimulant laxatives, or when high-dose stimulant laxatives are not tolerated. So this would be in in addition to.

SPEAKER_00

Okay, got it. Or, or if not tolerated, but yes. Um, so that's good clarification. So you may see patients continuing on their laxative that they've been on and adding this to provide additional relief. And how long would you wait for to see the effect of those non-pharmacologic and pharmacologic measures that we talked about before before thinking about adding this? What in in terms of pros, cons, and and placement therapy broadly, what what would make you think, okay, it's been long enough that we should consider adding something else?

SPEAKER_01

Yeah, I think, you know, the the challenge is always also making sure that your diagnosis of exclusion stays a diagnosis of exclusion. So I would say probably, you know, it wouldn't be happening at your first, you know, outpatient visit meeting the provider. But I would say after, you know, try having a good try of say, I don't know, three to six months, trying to see, you know, does that cause a benefit? Or is it time that we, you know, switch and try to add something else? I think the other thing that's I feel like I've learned a lot uh after you know finishing residency was that you know, you want to also make sure that you're not doing everything all at once so you can see what's actually working. And so I think, you know, trying out the cognitive behavioral therapy is great, trying that hydro stimulant laxative. And then if those don't work, not just reaching right away, but maybe giving it, you know, three months just to see, three, six, three, six months maybe to see and make sure.

SPEAKER_00

Right, which can be frustrating again because it this can affect quality of life and oh for sure.

SPEAKER_02

Yeah.

SPEAKER_00

Yeah, yeah. So very can be frustrating to have to spend that long. But as you say, not adding something unnecessarily when you you don't even know yet if if what you're trying is is effective. Yeah, and you mentioned the insurance coverage before. I didn't think that that is an

Practical Counseling And Insurance Hurdles

SPEAKER_00

important point. You also mentioned the because it is it is brand only. And so the cost is a consideration. You also mentioned diarrhea can be a side effect, which of course is sort of the uh intended effect, but can also be a side effect. And uh taking it on the weekend is a great little practical tip. I think what what other general counseling points are we wanting to think about if a patient is going to be starting this?

SPEAKER_01

Yeah, so I think, you know, um realistically, when they come to a clinic that day and you get the prescription for it and you're e-prescribing it wherever it's going to go, it's likely going to, if it does go through for insurance, that's awesome. Um, but likely there'll be some sort of prior authorization, I would guess, or have to have a peer-to-peer discussion about the patient if there is a denial. So I think that that's something that I would anticipate. I think another big part is family education, right? And so really uh I think that this is where our providers do a great job sitting down with the family and talking through a functional disorder and how you know it's not going to be seen on X-ray. It's not going to be C on that CT scan. You have to kind of think of it more so as migraines, right? And so for a migraine, and usually families do a good job at knowing, you know, I know what a migraine is, where it's not something that you can physically see on an exam, but you know it's there. And so a lot of the time our providers like to talk about it similar to migraines for counseling points. So it's contraindicated in kids that are less than two years old. And that's because of the diarrhea aspect of it. There is a chance that you could have severe diarrhea where you would have to get the patient rehydrated. And so that would be kind of one of your big concerns. It technically has that you should take it in the morning 30 minutes before breakfast, because if you have a high fat breakfast, you can have loose stools and greater stool frequency. But a lot of these kids, if you're thinking about who's our patient population that we're talking about, these kids aren't having a lot of bowel movements. That's why we're starting the medication, right? Yeah, right, right. They've been on an osmotic, they've been on these hydrostimulant laxatives, and you know, the parents and the patient are, you know, wanting to get through this. They want to have that bowel movement. And so some of our providers will even say, you know, take it at breakfast in the morning to try to have that stool.

SPEAKER_00

Interesting. Okay.

SPEAKER_01

Uh, and then another one is going to be uh if you have difficulty swallowing, and so that's the other big thing to think about in pediatrics. And so a seven-year-old might be able to swallow a pill or a capsule. They might not. And if they're not able to, you can open up the capsule and mix it with five uh mLs or one teaspoon of applesauce and eat it. Or you can put it into 30 mls of water, you want to mix it for about five minutes. The drug is actually on the beads itself in the capsule.

SPEAKER_02

Okay.

SPEAKER_01

And so the water itself, the drug will disperse into the water, but the beads might still be there. And so it's important you want to drink the whole thing. But if the beads are if there's a couple of beads left over in the bottom, the drug has already been uh given to the patient and that you don't have to finish every single little bead.

SPEAKER_00

Okay, that's a good clarification. Yeah, yep. Okay. Yeah. So again, very practical considerations, especially for this population to be thinking about um administration, that is always a consideration. We are about out of time. Any other general takeaways we need to be thinking about with this drug or IBSC in general with pediatric patients, unique considerations for us to be remembering as we're chatting with these patients?

Red Flags And The Game Changer Takeaway

SPEAKER_01

Yeah, I think you know, some of the key, you know, red flags that would be a reason why, you know, if you were talking to a patient uh that you should refer them to go talk to their healthcare provider would be if they have weight loss from this medication, uh if they have decreased growth velocity, if they have blood in the stool, because these could all be signs that they actually have IBSD or IBD, which would be um, you know, Crohn's or UC, as well as if they're having nocturnal symptoms, because that could also be. So if they're waking up in the middle of the night to stool more frequently.

SPEAKER_00

Okay.

SPEAKER_01

But otherwise, you know, I think it's a great medication. I think that you know, it's a really nice to have another medication to try for these patients.

SPEAKER_00

Yeah, considering uh the fairly limited options available, you're right. It to have an option, options are are good. And again, some of that trial and error can take time, but um, at least it it is an option to be considering in addition to sort of those tried and true methods. And I know you mentioned before we started the podcast that you've seen this already in practice in in your population. So it's interesting to see how it might shake out once we get more, you know, real world use.

SPEAKER_01

Yeah. And there has been times that, you know, you know, if you're submitting for insurance and after a denial, if you're doing a peer-to-peer, there's been multiple times where we've had to submit um, you know, posters from different poster presentations and conferences because that data isn't actually released yet, which is interesting. So actually in the package insert for uh linoclotide, the data that they have for their trial actually isn't in any publication yet. My guess is that it's going to be coming in the near future, but it's the study that they're using for that package insert is actually in the functional constipation phase three clinical trials supplementary appendix.

SPEAKER_00

Okay.

SPEAKER_01

I'm guessing that it's I'm guessing that the paper is coming soon, but they just haven't actually had that paper yet. So sometimes it is unpublished data. So trying to figure out your best bet of, you know, where does the data live? Uh, and that's where staying with different organizations, those professional organizations, can be extremely helpful. And working with other colleagues to see have you seen this before? And if you have, is there any areas that we can, you know, you know, try to see if that information is out there and do you have information on it that I could submit for this patient to try to do best for the patient.

SPEAKER_00

Yeah, yeah, that's interesting. And again, a very uh unique consideration with pediatric population in general and some of those uh considerations there. But uh thank you so much, Christopher, for for sort of enlightening us on IBSC in general, how it compares to the other other forms of constipation, thinking about the treatment options we have and and where linaclottide might fit in, knowing that treatment still needs to be individualized. But I really appreciate your point too about supporting those families and ensuring that the family is on board and working through some of the options available. So thank you so much. And um to wrap up our discussion, this is the Game Changers podcast. So we always wrap up with what do you think is the game changer that you'd want our listeners to walk away with about this topic?

SPEAKER_01

Yeah, I think the game changer is uh, you know, you're giving them, you have a patient who is, you know, refractory to the current management that they have for IBSC. And now you have a medication that you can try that's a um cyclic uh guanoline cyclase agonist that could hopefully help them have more spontaneous bowel movements, have you know less abdominal pain, and they might have some abdominal uh sustension and a little bit of bloating and diarrhea. But overall it seems safe and effective. So I think that that's really the game changer for it.

SPEAKER_00

All right, that we have a new option. And um with again, as you say, with generally limited data in this population, so good to have another option available. Excellent. Well, Christopher, thank you so much for your time. We really appreciate it. And uh just look forward to having you again on this podcast. It's it's been a great sort of enlightening considerations with the with this population, I think, for me anyway. And so um glad to have your expertise here.

SPEAKER_01

Yeah, thank you so much. It was great. I enjoyed it. Excellent.

SPEAKER_00

Excellent. Well, listeners, we talked about a lot of very great practical tips today, and these will all be summarized in the practice resource that goes along with this podcast and is included in the CE subscription. And be sure to claim your CE credit for this episode of Game Changers by logging in at CEimpact.com. And as always, have a great week and keep learning. I can't wait to dig into another game changing topic with you all next week.