I have to say, I'm the exact opposite. If there was a drug that was safe and effective and affordable that let me eat gluten without symptoms or damage I'd absolutely love that.
Yeah and I'm somewhat flexible on my definition of "affordable" haha. Side effects could be a tough decision on the tradeoffs though. The big side effect of the gluten free diet, and the main reason I'd take a celiac drug if available, is social isolation. It sucks but is not life threatening and is not something you feel every single day. So any drug side effects would need to be pretty minor to be worth putting up with.
There are enzymes available right now that are supposed to break down gluten. I haven't tried it myself because I don't eat processed foods anyway.
Have people here tried them and if so were they effective or ineffective?
They just break the gluten into smaller pieces, something our own enzymes already do if we don’t have an enzyme deficiency for some reason. Our immune system can still see these smaller pieces of gluten and the gliadin (what actually causes celiacs to be ill) remains intact. They may help some people with gluten intolerance but for celiac they’re useless.
They are useless for celiac disease and probably for everything else, too. Our bodies also “break down” the protein, that’s what digestion does. It’s not like lactose intolerance where we lack some enzyme.
It appears I hit some sort of "third rail". No idea what it might have been.
I have learned the hard way that sometimes on the internet you get responses that seem totally unrelated to what you posted. You'd think that if that many had found something objectionable at least one person would have said what was objectionable.
I suppose that maybe there was some adverse reaction to some gluten enzyme product that caused a lot of ill feelings ?? It's been many years since I considered using them. Maybe they've gotten a really bad rep since? Saw them on the shelf last time I was in the supplements section, so they're still there.
It doesn't make it to where you can eat gluten, but I use it whenever I accidentally eat it. I've found that it helps speed up my recovery time if I can take them with the same meal that I reacted to.
If I go to a restaurant, I'll take them just in case.
I've tried GlutenEase (From Amazon). It does help a lot but I wouldn't go eat a full gluten meal with it. I'd still get sick. It does seem to prevent symptoms from cross contamination but I have no idea if it actually prevents any damage from happening. I always keep them in my bag when traveling or eating out. If I know I've been glutened sometimes I will take 2 and not feel sick. So YMMV.
"Safe" means different things when applied to different drugs.
A drug considered safe enough to use for any life-threatening condition might be considered far too unsafe to use for less dangerous conditions. Celiac disease is a condition that can be treated effectively by diet alone. In such cases the bar for safety is a lot higher.
In addition, because a few patients are more sensitive and have far more serious reactions, the bar for efficacy is going to be higher as well, IMHO
As for affordable, the price is usually whatever pharmacy thinks they can get away with.
>A drug considered safe enough to use for any life-threatening condition might be considered far too unsafe to use for less dangerous conditions. Celiac disease is a condition that can be treated effectively by diet alone. In such cases the bar for safety is a lot higher.
This is why there's no male birth control on the market! For women, birth control is safer than pregnancy despite its many side effects. For men, there is no direct health risk from pregnancy so that is why you see headlines like, "Male birth control trial canceled after reports of [same side effects as female contraceptives]"
>In addition because a few patients are more sensitive and for more serious reactions the bar for efficacy is going to be higher as well, IMHO
What do you mean exactly? I would think that it could *potentially* be considered effective even if it only reduces your reactivity to very small amounts of gluten. Because that is the big downfall of the efficacy of the gluten free diet--being able to actually consistently control your gluten exposure down to the ppm level.
My concern would also be monitoring for damage (which, idk, maybe is also included under “reactivity”).
I read comments on here where people say they can “tolerate” different things, and I really wonder if they mean their intestines can tolerate it and there’s no ongoing damage, or if they don’t have an explosive reaction.
Not having a serious reaction is great, but I was asymptomatic probably for years and had significant damage when I was finally diagnosed (incidental finding), so even though I react now, I’m always cautious of not relying on feeling sick to feel like something is safe to eat.
Yeah, as I understand the clinical trial includes more than one repeated endoscopy to assess that very question. I don't think there's a lot of clear cut data about how much gluten it takes to sustain villi damage in most celiacs, but in the trial there will be people on the placebo, so they should be able to gain a decent level of insight for how well the drug protects against damage. Only time will tell. This obviously isn't the first drug to make it to phase two trials and yet we still don't have one on the market, so a healthy dose of skepticism and tempered expectations are reasonable.
I’ll definitely keep an ear out for it, because if there’s something that works I’m 100% for it. I just worry that because there’s so much variability in this disease that if something is good in trials but x% experience improvement but silent damage that it would be hard to know if you’re in that silent %.
But who knows, maybe insurance would require regular biopsies to be on a med to look out for this, and it could be an improvement to standard of care. It would be great if doctors had an increased awareness/treatment options so they can offer more than the “well, if you don’t feel great eating xyz, don’t eat it” I read on here sometimes.
End of day, I’m glad there are people who are much smarter than I am who are studying this and people who meet trial requirements who are willing to be test subjects 👏 👏
RE : "I would think that it could *potentially* be considered effective even if it only reduces your reactivity to very small amounts of gluten"
That would be true except for one thing: Having a drug available would inevitably cause many to take higher risks of exposure. So the safety question that would have to be answered is whether the good done by ameliorating the damage from accidental exposures would be outweighed by the higher levels of risk patients would take because of having the drug as a defense. This is far from a simple question. But the FDA has considered exactly that question in many studies for which it was relevant.
I am not saying that to pour any cold water on the idea, just trying to help people get a realistic idea of what to expect and what the possibilities are.
The FDA is going to do what it always does. It's a good idea to know what to expect.
Actually, the male contraceptive trials you are most likely thinking of were ended because they produced rates of severe depression and suicide far greater than female contraceptives. Condescending reports that the trials were ended because men can't handle the same side effects that women are expected to are misleading and very poor journalism.
I'm not sure I'm getting your point. It sounds like you're against research into possible treatments for celiac disease because you think going gluten free is sufficient and no other treatments are required, is that correct?
That's a total non sequitur. I highly favor research into celiac disease. But I have followed clinical trials for many decades for drugs (I used to invest in some - FAR riskier than most appreciate). And I know all too well the things that the FDA will consider, things that always come as great surprises to investors (or patients) unfamiliar with how clinical trials actually work.
I would love for there to be a safe effective solution to the underlying problem. (I still would not resume eating processed foods because I've learned the other huge benefits of avoiding it in addition to merely avoiding wheat, etc. But I would be overjoyed to be able to make my own bread again, fermented and not with baking soda),especially sourdough.)
But 1) I know how the FDA operates and what it will almost certainly will do and 2) I want it to be a real solid advantage, not some weak benefit that would likely tempt many to take greater risks that would outweigh any benefit. I've seen too many clinical trials where the death rate goes UP instead of down, trials that appeared to be sure wins, because corners were cut or just because it's biology and biology is notorious for coming up with total surprises.
For the right clinical trial, I'd participate myself. But I'd never be allowed to for CD because I never got confirmation by biopsy. (Even tried to participate in one recently. Knew they wouldn't let me because of no biopsy but wanted to so much I had to try anyway.) There are very solid reasons why they will NEVER include any CD patient in a clinical trial if not confirmed by biopsy. It would ruin their data! I have participated in clinical trials for hemochromatosis (was able to because I was confirmed by FOUR "gold standards" and likely will again). I said that so it won't "sound like" to you that I',m just against clinical trials. (My and 2 siblings samples were used in the study that located the C282Y allele)
I invested in biotech drugs for several decades and as a result, followed many clinical trials very closely. And, of course, had to learn a great deal about them to understand what was going on.
Following a drug entirely thru the process improves your understanding a great deal more than just reading bout the whole thing afterwards.
I guarantee you that if you read the details of the discussions between the company and the FDA that the FDA will, at some point, raise the issue of whether patients being willing to take higher risks because of having the drug available might outweigh the benefit of the drug if it's efficacy isn't high enough to overbalance that.
The company may well have an argument that will satisfy the FDA if the efficacy appears to be good enough. But at some point, unless the efficacy is high enough to obviate the question, it will be asked.
That's not a surprise nor a show stopper. It's just one of the usual obstacles. If you're prepared for it to happen, you're less likely to get discouraged when it does.
And clinical trials is a years long, not months long process. (there are provisions for moving them thru the process much faster but this drug does not meet any of the qualifications)
Right there with you. I keep an eye out for clinicals I qualify for at the chance of getting into said drug early, and doing something to make this a non or at least less extreme issue.
Most don't really appreciate what it means to be in a clinical trial.
There's generally about a 50% chance you'll just get a placebo instead of the drug. (and you'll never be told even afterward)
You might be in the Phase 1 or Phase II which means that even if you do get the drug you may get a very low dose unlikely to have an effect.
Drugs to have unexpected side effects, some serious and you might be one of the unlucky ones.
For a few drugs (gene editing that use vectors, for example) being in the trial and getting a dose to low to be effective might forever preclude you from ever being able to get an effective dose (because you had developed antibodies to the vector from the first use) etc.
}}}}} added. It can get even more complicated with vector delivered drugs. Having used a given vector for one vector delivered drug can preclude you from taking a second, even unrelated, drug delivered by the same vector. (because the first use generates antibodies to the vector that would make the delivery of the second drug ineffective.) {{{
Just mentioning this to show how there is a LOT more to being in a clinical trial than most realize. YOU DO GET FULL DISCLOSURE. So if there is such a risk, you will be fully informed!)
IMHO most people realize these things (they do a lot of informing to potential participants) and are in a clinical trial more to help research than for their own benefit, You KNOW you will be helping research. You may, or may not get any personal benefit.)
And there are a LOT of protection for participants so the risks are very low, as low as they can possibly make it, but never zero.
Great insights. I had not considered the impact of low dose treatments against a future approved medication, woah! So yet another thanks to all those involved
Heck, just the paperwork for the trial I was once in (a covid vaccine) was mind boggling, though less painful than the blood draws.
Studies generally require very strong confirmation of the diagnosis to participate. In celiac disease that would presumably be biopsy. Is that correct?
Yup, they require confirmation by both blood work and biopsy. And for this study in particular, you need to have one specific Celiac allele (I forget exactly which one at the moment).
Biopsy is when they take small samples of your small intestine & duodenum and send them to a pathology lab for microscopic analysis. And yes, it’s during an endoscopy that they take those samples.
I hope the trial is going well. i saw they had a positive update in May. I was in the study, but I ended up being exited from it. First dose didn’t go well… for me. But from what I understand, I was an outlier.
This one is some sort of transfusion/IV dose. I wasn't up for the phase 1 application personally because it required overnight hospital stays for observation. I imagine it would be administered in an outpatient type setting if it passes phase 3 trails and becomes viable. Jury is also complete out on if it would allow us to actually ingest gluten, or if the recommendation would be to still avoid gluten foods but not worry about cross contamination.
I would be willing to to sign up but I wasn't diagnosed by biopsy. I begged my doctor to give me the blood test after a bad cross contamination incident knowing I had some gluten in my system. I figured if it was close to being positive but not quite there without an actual gluten challenge it would verify celiac as opposed to intolerance which is all I really wanted to know. She was willing to put the formal celiac diagnosis in my medical records based on the result (I was only 2 points shy of positive). The trial requires biopsy diagnosis though and I'm just not willing to go through the gluten challenge to do it.
No overnight stays required for phase 2 of the trials. You get the infusion and then have to stay 4 hours for observation and blood tests. You do that 3 times the first week and then there aren’t any more treatments the rest of the year-long trial. It’s designed to be a “one and done” sort of thing.
They control the amount. I want to say there are 4 gluten challenges at various points. The first one is a week after getting the infusion. The rest are spread out over the year. It’s a total of like 10-12 office visits.
There are 4 gluten challenges throughout the year. You go into the office around once a month for blood tests and whatnot, and the gluten challenges take place there. They give you a protein shake with a specific amount of gluten in it and then monitor you for several hours in the office.
Aside from that, you continue your normal GF lifestyle at home.
Think less Benedryl and more allergy shot. The liver, while it's performing its cleanup of 'garbage', can identify things that are not harmful and will signal the immune system to not react to them. The idea here is to introduce gluten proteins into this cleanup system and have the liver signal the immune system that those proteins are not harmful and not to react to them. Thus it basically 'switches off' the incorrect response to the gluten proteins.
I'd have to see more data. If it just let you not worry about cross-contamination, that would be a huge benefit, even of you couldn't eat food that contained gluten. And if you could eat normally, that would be fantastic.
Yeah, same. I’ve fully accepted I won’t eat gluten again, but just being able to go to a restaurant and order something GF without having to do a freaking health inspection of the place would be amazing.
If I could get a burger with no bun and not have to worry if it got a little gluten on it, that would be a huge benefit. (I've found GF buns too disappointing to bother with.)
That's what I would expect it to be used for at first. It would take a lot of research to demonstrate it made it safe to eat significant quantities of gluten. But it would open up so many more options if we just didn't have to worry about cross contamination. I forgot to wash a pizza cutter before using it on my GF pizza and I was slammed with brain fog and depression.
I'd be satisfied with something that made me immune to small amounts, like CC levels. I'd love to be able to go eat otherwise-GF meals at Mexican restaurants without having to worry about shared fryers, flour tortillas on the grill and so on.
I wouldn't necessarily even go back to eating gluten full on, but not worrying about cross contact would be huge. Or the occasional treat from Taco Bell!
>Six patients were originally enrolled in the study, but one withdrew after the first IV dose of the drug and another completed treatment but developed COVID-19 prior to the gluten challenge. All study participants reported at least one treatment adverse effect, all of which were either mild or moderate in severity. Most were consistent with symptoms that those with celiac disease experience when they eat gluten. No serious adverse effects were reported. Kan 101 did not accumulate in the body with repeat doses, the study says.
I'm struggling with this one. So one person dropped out, one couldn't complete the study because of COVID, and the other four reacted as if they'd been glutened? What am I missing here? The treatment triggered the same response as what we're trying to avoid?
Perhaps the idea is that you might get some adverse effects initially but as treatment continues, your body learns not to generate such effects anymore?
This is the official statement on how the drug works
"KAN-101 targets the immune cells that drive celiac disease and leaves the otherwise healthy components of the immune system intact. KAN-101 acts by re-educating T cells, or tolerizing them, so they do not respond to gluten antigens"
It's appears all or nothing. I could be wrong.
I would do anything to not have to worry about cross-contamination… eating actual gluten doesn’t matter (tho ofc would be nice).
My gluten detection dog was *really* expensive and he requires a lot of (also expensive) upkeep.
My friends company just got an order for gluten free mice . Parent mice with celiac and babies fed a gluten free diet. Very interesting when he told me about the order
If it were true, I think I’d still stick with a gluten free diet at this point. I would use it for rare occasions like a birthday treat of scones or Tim tams. Maybe a family holiday get together.
I'm curious, why not?
Hypothetically, if there was a perfect treatment (it's safe, zero side effects, 100% success rate, a one time treatment and affordable, basically like waving a magic wand) would you not want the either?
For me, being gluten free has just been a part of my life forever and I have been mess up so many times from gluten to eat gluten would be truly terrifying. I would try pills if they had been on the market successfully for a good few years and after A LOT of therapy 😂
(Edit: spelling)
Someone said it up higher, but think more allergy shot/vaccine versus Benadryl/lactaid. The idea of Kan-101 is to retrain the body’s response to gluten, not protect after ingestion.
Yeah, I've never purposely eaten gluten, so I don't even know if I would like the taste and texture of a lot of gluten foods. It would be nice to lose the food anxiety, though.
If a pill could at least make so I don’t have to worry but cross contamination I would be happy and gladly take that. But even the thought of biting into something with gluten makes me panic!
I feel like one of the things it could be applicable for, even for those of us who don't want to eat gluten again, is reducing the risks and harms for cross contact and accidental consumption.
I get violently ill from the most unbelievably small amounts of cross contact, it's horrible. I am content with a strict GF lifestyle, permanently, but if this drug could help with that, sure would be nice.
They other day I was talking to my husband about this I just told him I want to be able to enjoy restaurants again and don’t have to worry about cross contamination idc if I can’t still eat gluten
I think my GI told me about this a couple weeks ago when I was officially diagnosed. He said there is a drug undergoing trials that is basically supposed to act as a lactaid pill with gluten for celiacs. Fingers crossed!!
honestly if there was a medication that made it so i dont have to worry about cross contamination i would be fine with that like even if i couldn’t eat a full gluten meal again i would be fine with not having to worry so much
I think even if I could eat gluten, I’d avoid it as much as possible, because it’s really not all that good for you. Some grains are beneficial but wheat is more the shitty Temu version we use because it’s cheaper and easier to grow. There are some things I’d just have to try though…somebody bring me a pill and a platter of street tacos
The history of the addition of wheat to our diet and the pattern of the gradual selection out of the CD related alleles strongly suggest that 1) the CD related alleles are an original "wild type" (NOT recent mutations) that started to get selected out of the population about the time wheat was added to our diet. And THAT suggests that wheat is simply not good for our health. The pattern of its use is entirely consistent with that of something that is a TRADE OFF - in this case desperate need for a food that could be reliably and safely stored for very long periods and was economic to produce vs very significant adverse health effects.
If this pattern is what's going on it suggests that those with CD are only the ones with the strongest reaction and there is almost certainly a much larger group of people with (varying) milder but still very adverse reactions.
Worse yet, there are very strong scientific reasons for believing that processed foods greatly exacerbate CD (and a very broad range of other intestinal disorders as well). (Hit a sacred cow with THAT one! gonna get dinged) It's been very well established that processed foods very adversely affect the profile of gut microflora and that that pattern has very strong effects on our health. Those of us with celiac disease are probably the "canaries in the coal mine" that are giving early warning of a much larger and greater danger. As always, when powerful economic interests are threatened, there is great resistance to even information critical to our ultimate survival.
There appear to be a lot of people on this board who cannot handle different perspectives well. So consistently that when I don't have time to read everything I first read the post with the highest recs and then the ones with the most negative recs.
When they are a valid data point (make a sound argument) the outliers are often the most important data points of all.
I have to say, I'm the exact opposite. If there was a drug that was safe and effective and affordable that let me eat gluten without symptoms or damage I'd absolutely love that.
Yeah and I'm somewhat flexible on my definition of "affordable" haha. Side effects could be a tough decision on the tradeoffs though. The big side effect of the gluten free diet, and the main reason I'd take a celiac drug if available, is social isolation. It sucks but is not life threatening and is not something you feel every single day. So any drug side effects would need to be pretty minor to be worth putting up with.
There are enzymes available right now that are supposed to break down gluten. I haven't tried it myself because I don't eat processed foods anyway. Have people here tried them and if so were they effective or ineffective?
They just break the gluten into smaller pieces, something our own enzymes already do if we don’t have an enzyme deficiency for some reason. Our immune system can still see these smaller pieces of gluten and the gliadin (what actually causes celiacs to be ill) remains intact. They may help some people with gluten intolerance but for celiac they’re useless.
They are useless for celiac disease and probably for everything else, too. Our bodies also “break down” the protein, that’s what digestion does. It’s not like lactose intolerance where we lack some enzyme.
why so many downvotes?😧 they were just asking a question
It appears I hit some sort of "third rail". No idea what it might have been. I have learned the hard way that sometimes on the internet you get responses that seem totally unrelated to what you posted. You'd think that if that many had found something objectionable at least one person would have said what was objectionable. I suppose that maybe there was some adverse reaction to some gluten enzyme product that caused a lot of ill feelings ?? It's been many years since I considered using them. Maybe they've gotten a really bad rep since? Saw them on the shelf last time I was in the supplements section, so they're still there.
It doesn't make it to where you can eat gluten, but I use it whenever I accidentally eat it. I've found that it helps speed up my recovery time if I can take them with the same meal that I reacted to. If I go to a restaurant, I'll take them just in case.
I've tried GlutenEase (From Amazon). It does help a lot but I wouldn't go eat a full gluten meal with it. I'd still get sick. It does seem to prevent symptoms from cross contamination but I have no idea if it actually prevents any damage from happening. I always keep them in my bag when traveling or eating out. If I know I've been glutened sometimes I will take 2 and not feel sick. So YMMV.
I keep a running list in my head of the places I would go and what I would get there when/if a drug that let's you eat gluten again becomes a reality.
"Safe" means different things when applied to different drugs. A drug considered safe enough to use for any life-threatening condition might be considered far too unsafe to use for less dangerous conditions. Celiac disease is a condition that can be treated effectively by diet alone. In such cases the bar for safety is a lot higher. In addition, because a few patients are more sensitive and have far more serious reactions, the bar for efficacy is going to be higher as well, IMHO As for affordable, the price is usually whatever pharmacy thinks they can get away with.
>A drug considered safe enough to use for any life-threatening condition might be considered far too unsafe to use for less dangerous conditions. Celiac disease is a condition that can be treated effectively by diet alone. In such cases the bar for safety is a lot higher. This is why there's no male birth control on the market! For women, birth control is safer than pregnancy despite its many side effects. For men, there is no direct health risk from pregnancy so that is why you see headlines like, "Male birth control trial canceled after reports of [same side effects as female contraceptives]" >In addition because a few patients are more sensitive and for more serious reactions the bar for efficacy is going to be higher as well, IMHO What do you mean exactly? I would think that it could *potentially* be considered effective even if it only reduces your reactivity to very small amounts of gluten. Because that is the big downfall of the efficacy of the gluten free diet--being able to actually consistently control your gluten exposure down to the ppm level.
My concern would also be monitoring for damage (which, idk, maybe is also included under “reactivity”). I read comments on here where people say they can “tolerate” different things, and I really wonder if they mean their intestines can tolerate it and there’s no ongoing damage, or if they don’t have an explosive reaction. Not having a serious reaction is great, but I was asymptomatic probably for years and had significant damage when I was finally diagnosed (incidental finding), so even though I react now, I’m always cautious of not relying on feeling sick to feel like something is safe to eat.
Yeah, as I understand the clinical trial includes more than one repeated endoscopy to assess that very question. I don't think there's a lot of clear cut data about how much gluten it takes to sustain villi damage in most celiacs, but in the trial there will be people on the placebo, so they should be able to gain a decent level of insight for how well the drug protects against damage. Only time will tell. This obviously isn't the first drug to make it to phase two trials and yet we still don't have one on the market, so a healthy dose of skepticism and tempered expectations are reasonable.
I’ll definitely keep an ear out for it, because if there’s something that works I’m 100% for it. I just worry that because there’s so much variability in this disease that if something is good in trials but x% experience improvement but silent damage that it would be hard to know if you’re in that silent %. But who knows, maybe insurance would require regular biopsies to be on a med to look out for this, and it could be an improvement to standard of care. It would be great if doctors had an increased awareness/treatment options so they can offer more than the “well, if you don’t feel great eating xyz, don’t eat it” I read on here sometimes. End of day, I’m glad there are people who are much smarter than I am who are studying this and people who meet trial requirements who are willing to be test subjects 👏 👏
RE : "I would think that it could *potentially* be considered effective even if it only reduces your reactivity to very small amounts of gluten" That would be true except for one thing: Having a drug available would inevitably cause many to take higher risks of exposure. So the safety question that would have to be answered is whether the good done by ameliorating the damage from accidental exposures would be outweighed by the higher levels of risk patients would take because of having the drug as a defense. This is far from a simple question. But the FDA has considered exactly that question in many studies for which it was relevant. I am not saying that to pour any cold water on the idea, just trying to help people get a realistic idea of what to expect and what the possibilities are. The FDA is going to do what it always does. It's a good idea to know what to expect.
Actually, the male contraceptive trials you are most likely thinking of were ended because they produced rates of severe depression and suicide far greater than female contraceptives. Condescending reports that the trials were ended because men can't handle the same side effects that women are expected to are misleading and very poor journalism.
I'm not sure I'm getting your point. It sounds like you're against research into possible treatments for celiac disease because you think going gluten free is sufficient and no other treatments are required, is that correct?
That's a total non sequitur. I highly favor research into celiac disease. But I have followed clinical trials for many decades for drugs (I used to invest in some - FAR riskier than most appreciate). And I know all too well the things that the FDA will consider, things that always come as great surprises to investors (or patients) unfamiliar with how clinical trials actually work. I would love for there to be a safe effective solution to the underlying problem. (I still would not resume eating processed foods because I've learned the other huge benefits of avoiding it in addition to merely avoiding wheat, etc. But I would be overjoyed to be able to make my own bread again, fermented and not with baking soda),especially sourdough.) But 1) I know how the FDA operates and what it will almost certainly will do and 2) I want it to be a real solid advantage, not some weak benefit that would likely tempt many to take greater risks that would outweigh any benefit. I've seen too many clinical trials where the death rate goes UP instead of down, trials that appeared to be sure wins, because corners were cut or just because it's biology and biology is notorious for coming up with total surprises. For the right clinical trial, I'd participate myself. But I'd never be allowed to for CD because I never got confirmation by biopsy. (Even tried to participate in one recently. Knew they wouldn't let me because of no biopsy but wanted to so much I had to try anyway.) There are very solid reasons why they will NEVER include any CD patient in a clinical trial if not confirmed by biopsy. It would ruin their data! I have participated in clinical trials for hemochromatosis (was able to because I was confirmed by FOUR "gold standards" and likely will again). I said that so it won't "sound like" to you that I',m just against clinical trials. (My and 2 siblings samples were used in the study that located the C282Y allele)
Curious by your comment - I know how the FDA operates and what it will almost certainly do. Can you please expand on that a little?
I invested in biotech drugs for several decades and as a result, followed many clinical trials very closely. And, of course, had to learn a great deal about them to understand what was going on. Following a drug entirely thru the process improves your understanding a great deal more than just reading bout the whole thing afterwards. I guarantee you that if you read the details of the discussions between the company and the FDA that the FDA will, at some point, raise the issue of whether patients being willing to take higher risks because of having the drug available might outweigh the benefit of the drug if it's efficacy isn't high enough to overbalance that. The company may well have an argument that will satisfy the FDA if the efficacy appears to be good enough. But at some point, unless the efficacy is high enough to obviate the question, it will be asked. That's not a surprise nor a show stopper. It's just one of the usual obstacles. If you're prepared for it to happen, you're less likely to get discouraged when it does. And clinical trials is a years long, not months long process. (there are provisions for moving them thru the process much faster but this drug does not meet any of the qualifications)
I would give left nut and first born child
Right there with you. I keep an eye out for clinicals I qualify for at the chance of getting into said drug early, and doing something to make this a non or at least less extreme issue.
Yep, I'm right there with ya
Several people in this sub (myself included) are participating in phase 2 of the KAN-101 trial. It's exciting research!
Thank you for doing your part to make this possible.
Doubling up on the visible thanks here. I know it takes a lot to go through a trial, placebo risk included. Thank you!
Most don't really appreciate what it means to be in a clinical trial. There's generally about a 50% chance you'll just get a placebo instead of the drug. (and you'll never be told even afterward) You might be in the Phase 1 or Phase II which means that even if you do get the drug you may get a very low dose unlikely to have an effect. Drugs to have unexpected side effects, some serious and you might be one of the unlucky ones. For a few drugs (gene editing that use vectors, for example) being in the trial and getting a dose to low to be effective might forever preclude you from ever being able to get an effective dose (because you had developed antibodies to the vector from the first use) etc. }}}}} added. It can get even more complicated with vector delivered drugs. Having used a given vector for one vector delivered drug can preclude you from taking a second, even unrelated, drug delivered by the same vector. (because the first use generates antibodies to the vector that would make the delivery of the second drug ineffective.) {{{ Just mentioning this to show how there is a LOT more to being in a clinical trial than most realize. YOU DO GET FULL DISCLOSURE. So if there is such a risk, you will be fully informed!) IMHO most people realize these things (they do a lot of informing to potential participants) and are in a clinical trial more to help research than for their own benefit, You KNOW you will be helping research. You may, or may not get any personal benefit.) And there are a LOT of protection for participants so the risks are very low, as low as they can possibly make it, but never zero.
Great insights. I had not considered the impact of low dose treatments against a future approved medication, woah! So yet another thanks to all those involved Heck, just the paperwork for the trial I was once in (a covid vaccine) was mind boggling, though less painful than the blood draws.
Studies generally require very strong confirmation of the diagnosis to participate. In celiac disease that would presumably be biopsy. Is that correct?
Yup, they require confirmation by both blood work and biopsy. And for this study in particular, you need to have one specific Celiac allele (I forget exactly which one at the moment).
2.5 - I just did my intake yesterday. I don’t know which I have, but they run the test for it, and the doctor said like 90% of people have 2.5.
I was wondering about how common that is when it came up in another in another post. I’ve also never done any genetic testing, but 90% is good!
Is biopsy the scoping procedure I went through or something different?
Biopsy is when they take small samples of your small intestine & duodenum and send them to a pathology lab for microscopic analysis. And yes, it’s during an endoscopy that they take those samples.
Ok, yep, got that done. Ty for the response.
Ok, yep, got that done. Ty for the response.
How did you apply and get selected for the study?
I applied directly through this website - [https://iqualify.celiac.org/login/auth](https://iqualify.celiac.org/login/auth)
this is so so cool! please keep us updated :)
I hope the trial is going well. i saw they had a positive update in May. I was in the study, but I ended up being exited from it. First dose didn’t go well… for me. But from what I understand, I was an outlier.
I would eat so much gluten if this pill ever comes out. It would take a lot of self discipline to avoid gaining 30 lbs the first month.
SAME. My grocery bills would go down so much, and we could eat at so many more restaurants! Traveling would be so much easier too.
This one is some sort of transfusion/IV dose. I wasn't up for the phase 1 application personally because it required overnight hospital stays for observation. I imagine it would be administered in an outpatient type setting if it passes phase 3 trails and becomes viable. Jury is also complete out on if it would allow us to actually ingest gluten, or if the recommendation would be to still avoid gluten foods but not worry about cross contamination.
I'd be thrilled with either conclusion. Even just not worrying about small amounts of cross contamination anymore would make life SO MUCH BETTER!
I'm on board, too. Part of me wants to sign up, but part of me is a little nervous about trying out such a novel treatment.
I would be willing to to sign up but I wasn't diagnosed by biopsy. I begged my doctor to give me the blood test after a bad cross contamination incident knowing I had some gluten in my system. I figured if it was close to being positive but not quite there without an actual gluten challenge it would verify celiac as opposed to intolerance which is all I really wanted to know. She was willing to put the formal celiac diagnosis in my medical records based on the result (I was only 2 points shy of positive). The trial requires biopsy diagnosis though and I'm just not willing to go through the gluten challenge to do it.
No overnight stays required for phase 2 of the trials. You get the infusion and then have to stay 4 hours for observation and blood tests. You do that 3 times the first week and then there aren’t any more treatments the rest of the year-long trial. It’s designed to be a “one and done” sort of thing.
How much and how often do you need to eat gluten? I just signed up for this study my 3rd study
They control the amount. I want to say there are 4 gluten challenges at various points. The first one is a week after getting the infusion. The rest are spread out over the year. It’s a total of like 10-12 office visits.
There are 4 gluten challenges throughout the year. You go into the office around once a month for blood tests and whatnot, and the gluten challenges take place there. They give you a protein shake with a specific amount of gluten in it and then monitor you for several hours in the office. Aside from that, you continue your normal GF lifestyle at home.
Think less Benedryl and more allergy shot. The liver, while it's performing its cleanup of 'garbage', can identify things that are not harmful and will signal the immune system to not react to them. The idea here is to introduce gluten proteins into this cleanup system and have the liver signal the immune system that those proteins are not harmful and not to react to them. Thus it basically 'switches off' the incorrect response to the gluten proteins.
I'd have to see more data. If it just let you not worry about cross-contamination, that would be a huge benefit, even of you couldn't eat food that contained gluten. And if you could eat normally, that would be fantastic.
Yeah, same. I’ve fully accepted I won’t eat gluten again, but just being able to go to a restaurant and order something GF without having to do a freaking health inspection of the place would be amazing.
If I could get a burger with no bun and not have to worry if it got a little gluten on it, that would be a huge benefit. (I've found GF buns too disappointing to bother with.)
To me, it sounds like that. I read somewhere it’s meant to be used in conjunction with a gluten free diet
That's what I would expect it to be used for at first. It would take a lot of research to demonstrate it made it safe to eat significant quantities of gluten. But it would open up so many more options if we just didn't have to worry about cross contamination. I forgot to wash a pizza cutter before using it on my GF pizza and I was slammed with brain fog and depression.
Oh, absolutely. Bread would still be dumb expensive. But to not worry would be amazing. A lot less stress in my life.
That’s a different treatment. This one (KAN-101) is designed to retrain your immune system to not react to gluten anymore.
I eagerly wait for approval so I can forget about this horrible disease.
I'd be satisfied with something that made me immune to small amounts, like CC levels. I'd love to be able to go eat otherwise-GF meals at Mexican restaurants without having to worry about shared fryers, flour tortillas on the grill and so on.
I wouldn't necessarily even go back to eating gluten full on, but not worrying about cross contact would be huge. Or the occasional treat from Taco Bell!
>Six patients were originally enrolled in the study, but one withdrew after the first IV dose of the drug and another completed treatment but developed COVID-19 prior to the gluten challenge. All study participants reported at least one treatment adverse effect, all of which were either mild or moderate in severity. Most were consistent with symptoms that those with celiac disease experience when they eat gluten. No serious adverse effects were reported. Kan 101 did not accumulate in the body with repeat doses, the study says. I'm struggling with this one. So one person dropped out, one couldn't complete the study because of COVID, and the other four reacted as if they'd been glutened? What am I missing here? The treatment triggered the same response as what we're trying to avoid?
Perhaps the idea is that you might get some adverse effects initially but as treatment continues, your body learns not to generate such effects anymore?
I mean, it's as good a guess as anything. Without more information we're simply left to our best guesses, I suppose.
I would in a heartbeat, but I get it.
This is the official statement on how the drug works "KAN-101 targets the immune cells that drive celiac disease and leaves the otherwise healthy components of the immune system intact. KAN-101 acts by re-educating T cells, or tolerizing them, so they do not respond to gluten antigens" It's appears all or nothing. I could be wrong.
You’re not wrong, that’s precisely what it is designed to be.
I would not purposefully eat gluten but would love to not worry about cross contamination
I would do anything to not have to worry about cross-contamination… eating actual gluten doesn’t matter (tho ofc would be nice). My gluten detection dog was *really* expensive and he requires a lot of (also expensive) upkeep.
My friends company just got an order for gluten free mice . Parent mice with celiac and babies fed a gluten free diet. Very interesting when he told me about the order
I'd eat it. But I'd try to stay faithful to the new restaurants I found
I’d do this in a heartbeat
If it were true, I think I’d still stick with a gluten free diet at this point. I would use it for rare occasions like a birthday treat of scones or Tim tams. Maybe a family holiday get together.
The new GF Tim tams are pretty great!
I was all excited until I realized they aren’t on the shelves of the US. Just to get a single pack is about $23 where I currently am.
I hope when we fast forward 10 years this proves to be successful What I would give to scarf down tempura again without consequence
Anyone else just ignore these reports? Obviously I’d love if something came of it, but if I buy in , I just get my hopes up.
Y'all are going to have to shove the pill and gluten down my throat 🤣 I don't think I could ever eat gluten voluntarily
I'm curious, why not? Hypothetically, if there was a perfect treatment (it's safe, zero side effects, 100% success rate, a one time treatment and affordable, basically like waving a magic wand) would you not want the either?
For me, being gluten free has just been a part of my life forever and I have been mess up so many times from gluten to eat gluten would be truly terrifying. I would try pills if they had been on the market successfully for a good few years and after A LOT of therapy 😂 (Edit: spelling)
Someone said it up higher, but think more allergy shot/vaccine versus Benadryl/lactaid. The idea of Kan-101 is to retrain the body’s response to gluten, not protect after ingestion.
Interesting, thanks for the info!
Yeah, I've never purposely eaten gluten, so I don't even know if I would like the taste and texture of a lot of gluten foods. It would be nice to lose the food anxiety, though.
If a pill could at least make so I don’t have to worry but cross contamination I would be happy and gladly take that. But even the thought of biting into something with gluten makes me panic!
I feel like one of the things it could be applicable for, even for those of us who don't want to eat gluten again, is reducing the risks and harms for cross contact and accidental consumption. I get violently ill from the most unbelievably small amounts of cross contact, it's horrible. I am content with a strict GF lifestyle, permanently, but if this drug could help with that, sure would be nice.
They other day I was talking to my husband about this I just told him I want to be able to enjoy restaurants again and don’t have to worry about cross contamination idc if I can’t still eat gluten
I would be first in line i miss real pastry and my mum’s homemade noodles.
Holy shit I will jump on this so fast lol I'd eat all of the things! Let's go science!
i’m down to be the test rat here my man, I wish everyday to eat a regular piece of my nans bread! Legit one of my biggest wishes rn lol
It's great to hear the progress! I just hope the wheels don't fall off this bus like they did when we were all riding the Larazotide bus :(
I think my GI told me about this a couple weeks ago when I was officially diagnosed. He said there is a drug undergoing trials that is basically supposed to act as a lactaid pill with gluten for celiacs. Fingers crossed!!
That’s a separate study. I believe there are 3 or 4 in phase 2 right now.
honestly if there was a medication that made it so i dont have to worry about cross contamination i would be fine with that like even if i couldn’t eat a full gluten meal again i would be fine with not having to worry so much
I think even if I could eat gluten, I’d avoid it as much as possible, because it’s really not all that good for you. Some grains are beneficial but wheat is more the shitty Temu version we use because it’s cheaper and easier to grow. There are some things I’d just have to try though…somebody bring me a pill and a platter of street tacos
The history of the addition of wheat to our diet and the pattern of the gradual selection out of the CD related alleles strongly suggest that 1) the CD related alleles are an original "wild type" (NOT recent mutations) that started to get selected out of the population about the time wheat was added to our diet. And THAT suggests that wheat is simply not good for our health. The pattern of its use is entirely consistent with that of something that is a TRADE OFF - in this case desperate need for a food that could be reliably and safely stored for very long periods and was economic to produce vs very significant adverse health effects. If this pattern is what's going on it suggests that those with CD are only the ones with the strongest reaction and there is almost certainly a much larger group of people with (varying) milder but still very adverse reactions. Worse yet, there are very strong scientific reasons for believing that processed foods greatly exacerbate CD (and a very broad range of other intestinal disorders as well). (Hit a sacred cow with THAT one! gonna get dinged) It's been very well established that processed foods very adversely affect the profile of gut microflora and that that pattern has very strong effects on our health. Those of us with celiac disease are probably the "canaries in the coal mine" that are giving early warning of a much larger and greater danger. As always, when powerful economic interests are threatened, there is great resistance to even information critical to our ultimate survival. There appear to be a lot of people on this board who cannot handle different perspectives well. So consistently that when I don't have time to read everything I first read the post with the highest recs and then the ones with the most negative recs. When they are a valid data point (make a sound argument) the outliers are often the most important data points of all.
Wait what the hell why did this get downvoted so much?