Celiac Disease Research Question

[T.H.]

Anyone know how the participants for most Celiac Disease studies are chosen? I'm assuming they are volunteers, but I honestly don't know. However, a fellow celiac's comment on a yahoo group re: a study got me thinking. She has fairly nasty reactions to gluten and mentioned that she would never volunteer for a study that required her to eat gluten.

So here's my thought: how many celiacs with severe reactions, or who react to lower levels of gluten, avoid Celiac Disease studies?

Could the research have difficulty reflecting the full spectrum of the disease because those who have worse reactions/more sensitivity to gluten simply aren't volunteering?

I don't know if this has ever been looked at - although if it has, I'd love it if anyone has some links to information on it. But I'm curious if this is something that could be a potential issue, ya know?

Like, maybe not a lot of research might involve those with neurological reactions, because these celiacs so often have permanent or debilitating reactions that they aren't taking any chances on ingesting gluten. And their reactions/experiences would not be added into our body of research.

Or perhaps research on what a gluten reaction is could be skewed as those with severe reactions aren't going to participate because their reactions ARE so severe.

Or, and this is the one that first popped into my heasd, could research on what levels of gluten are safe be skewed because most celiacs who react to lower levels don't wish to consume gluten at higher levels?

I really don't know how much difference this type of thing would make, but I'd be interested in hearing what others think about this as a research concern, or lack thereof.

[ravenwoodglass]

In every study I have ever looked at joining you have to be a blood and biopsy proven celiac. Not saying that is the case with all for sure. I think all the concerns you mention are valid. I would never join a study for the reasons you mentioned, even if they would let me. In the US celiac seems to be considered just a GI disease and all other symptoms are ignored to a large part. People that have doctors that realize that neuro issues and stuff like arthritis can be celiac related are very fortunate.

[dilettantesteph]

I don't think that they would include someone who isn't fully healed in a study which examines whether or not something is causing damage. For example, the Fasano study (referenced below) which was used to recommend the FDA limit of 20 ppm excluded a patient who had a full remission with the 10 mg/day gluten consumption rate. Someone who is sensitive to low levels is less likely to be fully healed than someone who is sensitive to higher levels because accidental gluten consumption would be more likely to cause damage. That would make the studies find a higher level of acceptable gluten consumption.

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[Mari]

Hi Shauna,

I have looked at several studies who were asking for volunteers. They all required the subjects to have had positive blood tests and small intestine biopsies. I had an elevated anti alpha gliadin but a mormal anti TtG, no biopsy, one hi risk main celiac gene (DQ8) and one gene putting me at risk for non-celiac sprue so I would not have been accepted. So yes the results are skewed toward the people with the positive results and ignored the 20 to 30 % of celiacs with incomplete testing, those who had too little of the antibodies when tested and people who are self-diagnosed. It is becoming more obvious that the criteria used for these studies have not been realistic. A recent study (didn't read the paper, just an article about the paper) has shown that people with positive tests and symptoms have the same metabolic profile as people with no symptoms. They concluded that all people who have a predisposition to celiac disease, or 'silent' celiac disease would be safer gluten free. The study also noted that the intestinal symptoms are more related to disturbed intestinal flora than the autoimmune reaction. Jefferson Adams, I think did the review of this paper in one of the newsletters or updates from celiac.com. Hope I;ve got this right.