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The tests sites have been updated on ClinicalTrials.gov for the Larazotide Acetate Phase 3 trial as of TODAY! There are now 14 sites listed – even one in ATLANTA! Heck Yeah! Guess who will be first in line for this one baby.

I’m not 100% convinced that this drug or even the trial is set up well, I’m willing to put my body on the line for science. Now that the trial is in my backyard, I’m happy to participate. I believed Nexvax was a cure. I’m worried that this is only a band aid and not even the best band aid for our situation. But, I want something on the market to help us. I want some freedom back.

If I’m going to get cross contaminated every place I eat outside my house, why should I deal with the consequences? I’m almost thinking of this like birth control – sex feels good and I don’t want the consequences of getting pregnant each time I have sex. But there is always the risk of an STD when using birth control. And damage to my small intestine could be the STD of this drug. Damage to my small intestine, STD, and pregnancy all have long term consequences. So, this is a powerful option that has to be used judiciously.

This is my dilemma with this drug and always has been. Where is the line? What is the difference between cross contamination and a full on gluten diet? Before diagnosis my diet was what most people would call gluten lite – would this drug be okay for that? I dunno.

I can justify anything and make an argument that this drug is bad or good. I can rail against it or prop it up like it was the greatest thing ever. I should probably wait and see what the science says.

Just so you know, I did have all of these issues and thoughts when evaluating Nexvax. My concerns were different there – manipulating my immune system and long term consequences were my biggest concerns with Nexvax. This is the same sort of thing.

While I’m not sure this is the cure we’ve all been looking for it might be the first step.

Also, I’ve learned that the FDA places a strong emphasis on reduction of symptoms rather than simply test results. So, that is probably why the results of this trial are only based on reported symptoms.

They say they are actively recruiting but there is no information regarding contacts. I think this update is ongoing and we will keep an eye on it.

Larazotide acetate is a tight junction regulator in the small intestine. According to Innovate Biopharmaceuticals, “a tight junction regulator, which helps restore “leaky” or open junctions to a normal state. In CeD patients, ingestion of gluten causes disruption or opening of the tight junctions. The open junctions cause an inflammatory cascade within the intestinal epithelium that eventually destroys the intestinal villi, decreasing the surface area for absorption of nutrients.”

Here’s the link for the clinical trial documentation. See if you are close enough to participate.

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