Celiac Patient Registry

neural networks
© Getty Images Plus/ IStock/ Evgeny gromov

iCureCeliac, a national celiac database, is addressing a critical need. It may impact the lives of everyone with celiac disease.

In 2016, the Celiac Disease Foundation launched iCureCeliac, a national registry of people with celiac disease and gluten sensitivity and their caregivers. We asked the Foundation’s CEO, Marilyn Geller, to tell us more about it and explain why we should all participate.

GF&M: Give us some background about iCureCeliac. How did it get started?

Marilyn Geller, CEO of the Celiac Disease Foundation
Marilyn Geller, CEO of the Celiac Disease Foundation

Marilyn Geller: The Celiac Disease Foundation was invited to collaborate with the Genetic Alliance, a coalition of organizations of genetically related diseases seeking to develop a shared platform for patient registry, funded by the Patient-Centered Outcomes Research Institute (PCORI). The hope was that data could be shared by researchers across 11 organizations to better understand the genetic linkages of these diseases. No longer would there be data silos for each individual disease; this was looking at the broader picture. The Foundation was approached because it has a strong history of one disease (celiac) and it’s flexible and agile in terms of developing a platform for the celiac community. We were asked to join and get up very quickly.

GF&M: Tell us about the registry. I’ve heard you say it’s “patient-outcome driven.” Can you explain what that means?

Geller: The registry is based on asking the opinions of patients and caregivers about everything related to daily life with celiac disease and related disorders, including non-celiac wheat sensitivity. For example, a group of questions delves into things like, what do you want a celiac treatment to look like? If it were an adjunct to the gluten-free diet, would it be a pill, a shot, an enzyme taken with each meal, an immunization? What side effects would you be willing to tolerate in a celiac treatment? How much would you be willing to pay?

The questions were structured by the Foundation’s medical advisory board with the intent that researchers could use this data to do everything from conceive of new treatments for celiac disease to supporting the celiac community through policy development, from the labeling of gluten-free foods and medications to strategies related to restaurants, schools and the workplace. This research and policy information would help shape a better life for those with celiac disease.

GF&M: What’s the goal of iCureCeliac?

Geller: There are four overarching goals: To increase the diagnostic rate of celiac disease, to find alternative treatments, to understand the long-term implications of the disease and to find a cure.

GF&M: Can you give an example of how iCureCeliac can have this kind of impact?

Geller: The data is already establishing the fact that there’s really a need for treatment besides the gluten-free diet. The historical opinion has been that celiac disease doesn’t need a drug or a vaccine, that no treatment is necessary. But the data we’ve collected thus far substantiates the fact that people need a treatment besides just a gluten-free diet.

GF&M: How does iCureCeliac data substantiate that?

Geller: It shows that, on average, participants miss 23 days of work or school per year due to celiac-related illness. You can call this getting “glutened.” That’s the reality and that starts to put a real economic cost to celiac disease.

Then there’s the fact that anywhere between 40 to 50 percent of iCureCeliac participants claim that the gluten-free diet is not effective—they’re still symptomatic. Even when they’re eating as strictly gluten-free as they think they can, there’s enough inadvertent gluten to cause illness.

These are just two examples of data that is changing the mindset of the bio-pharmaceutical community, which has the money to actually bring a celiac drug to market.

That’s just one part of it. In addition to the data, iCureCeliac is developing a cohort of patients nationwide who can participate in medical trials and in focus groups. The registry helps us locate celiac patients who are active, engaged and motivated to participate. They can help shape the future of celiac disease and be compensated for it.

GF&M: So iCureCeliac data is available to researchers?

Geller: Yes. The Celiac Disease Foundation is the only organization in the United States that makes celiac-related data publicly available to medical community researchers free of charge. Patient data is collected with informed consent, which means the resulting research can be published in peer-reviewed medical journals. In addition, iCureCeliac is Investigational Research Board (IRB) approved, so medical organizations and research groups across the country and overseas can use the registry and publish their findings. Already, Columbia University has produced two research papers using this data and there are more to come.

GF&M: Is the biopharmaceutical community charged for the data?

Geller: Yes. Biopharma has the dollars and there’s a fee. The Foundation’s goal is to put the data in the hands of our institutional researchers and to help them recruit for their trials. Research conducted by medical institutions convinces the biopharma community that there’s a viable reason to develop a drug.

GF&M: The registry was launched in 2016. Have people been signing up?

Geller: We have about 6,300 participants right now, a robust amount in the disease space for the number of years the registry has been operational. The celiac community has really rallied. We’re considered a preeminent success in terms of patient recruitment—but we still need more people to sign up.

GF&M: Are there privacy concerns about participating?

Geller: There are multiple layers of privacy protection. The registry has the highest level of security protection in addition to all the HIPAA security. The data is separated from participants’ identity. Called de-identified or anonymized data, researchers never see participants as individuals. The data is seen as an aggregate. Contact information is encoded and never identified.

GF&M: How do people sign up?

Geller: Go to celiac.org/icureceliac/ and click on “Join/Login.” Sign-up is free. It takes about 30 to 45 minutes to complete but you can stop and pick it up later.

GF&M: Can parents participate on behalf of their children?

Geller: Yes. Parents or caregivers can participate on behalf of their child under the age of 18.

GF&M: How is the registry funded? Do you seek donations?

Geller: Federal funding for the registry ran out under the current Administration. The Foundation is absorbing the cost internally. We rely on individual donors. Fortunately, we have a few significant donors who have helped with this and a myriad of smaller donors who help. The Foundation charges the biopharma companies for recruiting; that fee is lower than they usually pay for this. All this helps offset registry costs. But yes, we do need people to donate toward this. There’s no question.

GF&M: Why should people participate in iCureCeliac? Why should they donate?

Geller: Again, public opinion has generally been that celiac disease is not a serious disease, that research doesn’t have to focus on a treatment beyond the gluten-free diet. In actuality, celiac disease is a serious autoimmune condition. People with celiac disease continue to have health implications even after going gluten-free. And it is burdensome in terms of quality of life. People are drawn to iCureCeliac because they want to make certain that, if not for themselves, then their children won’t have to deal with these long-term health issues. They believe there’s celiac treatment and cure in the future and they want to help make that happen.

Founded in 1990, the Celiac Disease Foundation is a nonprofit organization located in Woodland Hills, California, with a mission to “accelerate diagnosis, treatments and a cure for celiac disease and non-celiac gluten/wheat sensitivity through research, education and advocacy.”