January 23, 2013 — Prominent celiac disease and gluten sensitivity researcher Dr. Alessio Fasano says he's "confident" that a clinical trial now underway will pinpoint a biological marker, or biomarker, for non-celiac gluten sensitivity, and that discovery should pave the way for the development of diagnostic tests for the condition.
The Center for Celiac Research — newly part of the Massachusetts General Hospital system — is collaborating with Second University of Naples on a clinical trial designed to identify a biomarker for gluten sensitivity. The trial, which is enrolling patients now, ultimately hopes to include about 120 people and is expected to wrap up this summer, although analysis of the data will take longer, Dr. Fasano told me in an interview.
Ultimately, the discovery of a gluten sensitivity biomarker and development of a gluten sensitivity test will help to increase awareness for the condition among both the public and physicians -- not to mention getting people diagnosed, he says. It also will make possible a study to determine just how many people actually have gluten sensitivity.
"The major problem we faced in the scientific community in general is the skepticism of the community to even accept there's such a thing as gluten sensitivity," Dr. Fasano says. Of course, several recent studies and scientific papers have provided what he calls "overwhelming" evidence that gluten sensitivity exists (read more in my article Non-Celiac Gluten Sensitivity Research). "So the discussion is shifting from 'Does it exist or not?' to 'How big a deal is it?'"
The only way to establish how many people suffer from gluten sensitivity is to identify a biomarker for the condition and then to perform a large study that screens a bunch of randomly chosen people for that biomarker, Dr. Fasano says. In fact, he and his colleagues performed and published a similar study about 10 years ago that established the prevalence of celiac disease in the U.S. at one in 133 people (previously, most doctors had thought celiac was extremely rare).
The current clinical trial is looking at possibly useful gluten sensitivity biomarkers that include markers that can be isolated from blood samples, along with measurements of gut barrier function (gluten sensitivity is thought to alter the permeability of your small intestine). Dr. Fasano's previous research has found differences in intestinal permeability between people with celiac disease and gluten sensitivity, along with differences in the expression of genes that regulate the immune system's response to gluten.
The number of people with gluten sensitivity could be far higher than the number of those with celiac disease, Dr. Fasano says. "My conservative estimate is that 6% [of the overall population] have gluten sensitivity."
Of course, the field of gluten sensitivity research is still very new. Here's more information on what we know (and don't know):