<<Disclaimer: Verify this information before applying it to your situation.>> Hi All-- My original question was: ...Will the AT-1001 pill that is undergoing phase 2 testing now, help the thousands of patients who don't have an iron-clad diagnosis proven by flattened villi...or is it aimed at only those celiacs who have measurable intestinal damage? I'm not trying to be antagonistic about this - I would really like to know. I think it's terrific that so many people will be helped by this drug, if it's approved! I'm just not sure who the target patient is. ~~~~~~~~~ I didn't have a huge number of responses, though I did receive several requests for a summary. The responses I did receive are below. Thanks to those who replied and made this issue much more understandable for me...and I hope others. ~~Ayn in Alabama _____ My understanding is that AT-1001 stops "leaky gut", which is a BIG DEAL. One of the major problems with gluten intolerance in general is that it causes zonulin production. Zonulin causes the gut barrier to become more porous. It also causes the blood-brain barrier to become more porous. Those two things probably account for a lot of the mental problems and autoimmune problems resulting from gluten intolerance. The problem is, this gut porosity doesn't always go away on a GF diet. Some people may be reacting to another food (like dairy) or to bacteria. So having a drug that would stop gut leakage will help resolve symptoms quickly. It probably won't stop people from feeling ill or getting diarrhea from gluten (bentonite does help with that though). AT-1001 might, for instance, be given to children at risk for T1 diabetes, or people with high levels of anti-thyroid hormones. Given early enough, this might save the thyroid or pancreas. SOME of these patients are probably gluten intolerant, but a lotof them might not be. This needs to be studied more, but so far it looks like maybe 10% of the T1 diabetes patients are celiac and respond to a GF diet. The other 90% don't respond to a GF diet ... no one right now knows how to help them. AT-1001 might. If you need to worry about "trace gluten" though, I'd recommend bentonite. A little clay with a meal (in a gel cap is easiest) really does mitigate the symptoms and makes it easier to eat out. Or after the fact, if you get "glutened", you can get back to normal faster. _____ There as a posting from Cynthia at the Gluten Tolerance Assn of North America recently saying definitively that the gluten pill will not work for celiacs. _____ -First, people with celiac disease who are asymptomatic or have symptoms outside the GI system. In theory, the pill should work for them because it is blocking the trigger to the immune reaction characteristic of CD. The immune reaction may not generate noticeable symptoms, and it can generate symptoms outside the GI tract--nonetheless, the celiac immune response begins in the gut. The pill *should* prevent it from occurring. -Secondly, there is no way to know if it will work for people with non-celiac gluten intolerance or gluten sensitivity. There are many people who do actually have CD who never got a definitive diagnosis. I am one. I am quite sure I have CD for a number of reasons (including a strong family history with two sisters with biopsy proven CD.) My biopsies were done when I was on prednisone, so they are unreliable. If the pill works at all, it should work with people like me. On the other hand, there are people who simply feel better not eating gluten who may not have CD. It's unlikely it will work for them. _____ It's a good question. From talking to Dr Fasano I gathered that the junctions that allow the gluten to "leak" where it shouldn't is exactly what AT1001 targets. I believe that all manifestations of CD, whether GI related or not will be stopped for the meal that is eaten after taking the pill. _____ I haven't had experience with this pill, but I do work in clinical trials and am knowledgeable about the process. So far, the pill has passed phase 1 testing which means that it has been shown to be safe in healthy humans. (I haven't read the actual results from phase 1 studies for this pill.) It is now being tested for phase 2--which is usually testing for the best, safest dose to give while also looking at efficacy--or how well the drug works. I'm not sure anyone can really answer your questions yet--because I'm sure the researchers are asking these same questions. I'm interested, too...because my husband is one of those non-biopsied, non-celiac diagnosed, gluten intolerant people that improves on a GF diet. * All posts for product information must include the applicable country * Archives are at: Http://Listserv.icors.org/SCRIPTS/WA-ICORS.EXE?LIST=CELIAC