Beyond Celiac just published the results of a survey of 4500 celiac patients and whether they would participate in a clinical trial.
Now, for me, I think participation in clinical trial is important. I think that without people participating in clinical trials – whether for a new drug or just to understand celiac more clearly – is vital.
They found that 13% of adults surveyed would be willing to do a long term gluten challenge of weeks or longer and the number doubled to 26% of celiac patients were willing to do a short term gluten challenge of one to three doses of gluten. Now, this is interesting. If these numbers are true, then that is about 450,000 of diagnosed celiac patients are willing to do a short term gluten challenge. That is a lot of people!
They also said that 86% were willing to take surveys and over 60% of those surveyed were willing to take blood tests or stool tests. Awesome! I love that high a percentage that people are willing to participate.
But this vast difference between people willing to consume gluten versus those that are willing to do surveys, blood tests, and stool tests is important. Thinking about drug trials, would you trust a drug trial that didn’t do a gluten trial? Personally, I wouldn’t simply because symptoms are tricky. Without a gluten trial, are people certain that their symptoms related to gluten? That is where I have a problem.
In reading about the Larazotide Acetate (INN-202) Phase 3 trial, they talk a lot about blood tests and symptom diaries. What they aren’t testing against is a gluten trial or even before and after endoscopies. Also, Larazotide Acetate is also known as a “tight junction regulator”. Which isn’t really attacking the gluten consumption as the problem, but instead is preventing leaky gut. Their contention is that gluten causes the tight junctions in the small intestine providing the lining in the intestine to open. This is true, but is keeping the tight junctions in tact enough to prevent celiac damage. I don’t know, that’s why they are stuyding this drug.
I will say, they now have 102 sites across the US, but it seems they aren’t recruiting. Maybe they are full. I really hope they are full, but I don’t think so because they estimate the end date of the trial to be August 2021.
I want to talk specifically to the twenty-six percent of people willing to consume gluten for a clinical trial. Thank you. Please know that the celiac community appreciates your willingness to put your body on the line to help discover a cure.
There might be pain involved with gluten consumption and hopefully the drug companies will realize that they need to provide comfort measures once the testing is complete. If they can provide fluids and anti-nausea or anti-diarrhea medicine after gluten consumption, I’m sure this percentage of willing participants will increase. If they can give something that will help with ongoing exhaustion or pain, that would be helpful too. But if we are willing to put our bodies on the line to help, the drug companies need to help us as well.
But my point to this is – we as a community have to participate in clinical trials. If you don’t want to consume gluten, there are lots and lots more studies going on that still need participation from our community. So, if you can, please participate in clinical trials if available.