Building on the momentum of our work in 2020 throughout the pandemic, the Celiac Disease Foundation decided that we could best serve the celiac disease patient community by keeping a tight focus on our agenda of research, advocacy, and education. Thanks to your support, we have been remarkably successful in advancing our shared mission over the past year. What follows are some highlights of some of our most important accomplishments.
RESEARCH
Clinical Trial Patient Recruitment When 2021 comes to a close, the Foundation will have supported 22 clinical research trials and studies for proposed celiac disease therapies through our extensive patient recruitment platforms and tools, most notably our iCureCeliac® patient registry and iQualifyCeliac, our screening software. We learned through research using iCureCeliac® that a majority of the celiac disease patient community suffers disease symptoms, often debilitating, despite strict adherence to the gluten-free diet. We also know that the long-term impacts of celiac disease on the human body and mind are devastating, including higher risks for heart disease, depression, cancer, other autoimmune diseases, and infertility to name a few. Our patient community desperately needs FDA-approved treatments and a cure.
Research Grants We announced this October a research grant to one of the world’s leading plant science labs at the University of California, Davis for a study, Development of a Novel Dietary Treatment for Celiac Disease, that may significantly reduce the suffering experienced by our patient community. The research being led by Dr. Jorge Dubcovsky and Dr. Wenjun Zhang, world experts on wheat, is using cutting-edge CRISPR technology to try and develop a wheat variety that is non-toxic to those with celiac disease or non-celiac gluten sensitivity. If scientists can moderate or eliminate the toxicity of gluten in wheat for celiac patients, then patients and those who care for them will have another option to more effectively manage the disease. It may also be possible that children who consume this less allergenic wheat may never develop celiac disease due to an overall decrease in exposure to toxic gluten. Although non-toxic wheat is likely years away, we believe that the potential reward of this investment far exceeds the risk. The Celiac Disease Foundation has granted UC Davis $360,000 to fund this phase one three-year research study.
NIH Accelerating Progress in Celiac Disease Workshop: In March of this year, NIAID hosted the Accelerating Progress in Celiac Disease Workshop, a two-day, virtual meeting catalyzed by the Foundation’s advocacy efforts in Washington, D.C., where CEO Marilyn Geller presented as the Patient Advocate. At this seminal workshop, experts in celiac disease and related areas identified opportunities for research and training of future investigators to inform NIH of the funding required to cure treat, and one day cure, celiac disease.
FDA GREAT VI Workshop: In July 2021, the Food and Drug Administration (FDA) hosted the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Celiac Disease – the second workshop ever held by the FDA for celiac disease. The goal of this workshop was for the FDA to better understand the role of measuring symptoms and intestinal healing in celiac disease as new therapeutics advance through the drug development pipeline. The Foundation was asked by the FDA to identify celiac disease patients and caregivers who would participate in this essential process. Amplifying the patient voice is one of the exact reasons we created and trained Patient Advocates through our Patient Education & Advocacy Summit and our online State Advocacy Ambassador Training Program over the last several years. We are proud to have three members of our Foundation family selected to participate in the GREAT VI Workshop.
Low Income Food Assistance Research Managing a gluten-free diet has always been challenging, but insert a pandemic and, for many people with celiac disease, it has become even more difficult. According to the USDA, 13.6% of households with children in the U.S. experienced food insecurity in 2019, which represents more than five million children. Since the start of the COVID-19 pandemic, the Brookings Institution reports that this number has dramatically increased to more than 27.5% of households with children experiencing food insecurity. We anticipate this to be the same for households with celiac disease. The Foundation in partnership with researchers at Boston Children’s Hospital are conducting a survey to establish the prevalence of food insecurity in households with celiac disease to better inform federal policy changes for low-income food assistance.
Published Research The Celiac Disease Foundation published two research studies in 2021. Each advanced understanding of the patient experience with celiac disease. In October at United European Gastroenterology Week (UEGW), the premier venue for researchers across the globe to present their latest findings, researchers from the pharmaceutical company, Takeda, the University of Sheffield, Columbia University, Coeliac UK, and the Celiac Disease Foundation virtually presented a study entitled, Experiences of a gluten-free diet in patients with celiac disease: a multi-national survey that detailed how many patients around the world struggle with accidental gluten-exposure despite their best efforts to maintain a strict gluten-free diet.
Probiotic Use in Celiac Disease: Results from a National Survey analyzed patient data from the Foundation’s iCureCeliac® patient registry, and was led by Andrew Joelson, MD, along with Marilyn Geller, Celiac Disease Foundation CEO, and Benjamin Lebwohl, MD. Researchers found that roughly one-third of celiac patients reported using probiotics for perceived health benefits, despite the lack of evidence that probiotics are an effective treatment for celiac disease symptoms. The researchers concluded that patients may be seeking additional means of treatment for persistent symptoms. This is why the Celiac Disease Foundation is devoting enormous energy and resources toward finding alternative treatments to the gluten-free diet and a cure.
ADVOCACY
In 2019, we launched our multi-pronged advocacy campaign in Washington, D.C. to secure research funding because researchers were telling us that progress toward treatments and a cure would continue to lag without substantial federal research investments.
NIH Funding for Celiac Disease Beginning with CEO Marilyn G. Geller’s testimony to the House and Senate Appropriations Subcommittees, we have obtained, for the second time, “report language” in NIH’s budget authorization instructing the National Institute of Allergy and Infectious Diseases (NIAID) to direct sufficient resources toward research for treatments and a cure for celiac disease. To compel Congress to approve this, it became clear that the Foundation needed to convene a meeting to develop a consensus to identify and prioritize high-yield areas of research. In March of 2020, the Celiac Disease Foundation, in partnership with the Society for the Study of Celiac Disease (SSCD), convened the first SSCD Consensus Workshop, “Research Opportunities in Celiac Disease,” at Columbia University. The Roadmap developed at the Consensus Workshop was published in September of this year, in a leading journal, Nature Reviews Gastroenterology and Hepatology. The Workshop accomplished everything we hoped for. The Roadmap informed our presentations at the May 2020 NIH Autoimmune Diseases Coordinating Committee meeting, the March 2021 NIH Accelerating Progress in Celiac Disease Workshop, and the July 2021 GREAT VI Workshop on Celiac Disease. All of this work, supported by Members of Congress at every step, has led to this: NIH has published a Notice of Special Interest funding opportunity for celiac disease, targeting much needed federal research dollars to the disease. NIH has also promised to implement new tools to track agency-wide funding of celiac disease research.
Celiac Caucus: This year marked the launch of the first Celiac Disease Caucus in Congress, an important milestone. The Caucus is chaired by Congresswoman Betty McCollum (DFL-MN), a respected leader in the House who has celiac disease. Already, 19 members have joined the Caucus and will be an influential force to guide the NIH and other federal agencies in supporting innovative celiac disease research and advancing legislation that promises to ease the suffering of celiac patients. The creation of the Celiac Disease Caucus has been one of the highest legislative priorities for the Celiac Disease Foundation and will allow for Members of Congress to convene, share information, elevate awareness of celiac disease, and amplify the voice of the patient community.
Patient Advocacy For the second consecutive year, the Celiac Disease Foundation hosted the Patient Education & Advocacy Summit, with a primary goal of training a new cadre of Celiac Disease Foundation State Advocacy Ambassadors to engage patients and legislators from their communities in the struggle to accelerate research for treatments and a cure. More than 1,700 people from around the country registered and participated in the virtual education and advocacy training experience, learning from the world’s leading celiac disease experts and policy analysts. Patients engaged with drug developers to share their experiences and needs for new therapies. The Summit was made possible by an engagement award from the Patient Centered Outcomes Research Institute (PCORI).
EDUCATION
Hosting the world’s most trafficked website for celiac disease, the Foundation’s website, celiac.org, remains the single most trusted source of information on the web for diagnosis, gluten-free diet management, news, research, and patient support. The companion app, Eat! Gluten-Free, is a one-stop destination for all things gluten-free, including the latest blog news, recipes, and products. The Foundation’s focused investment in healthcare provider and patient education continues to help end the needless suffering of millions.
Provider Education The Celiac Disease Foundation, once again, was proud to sponsor the University of Chicago Celiac Disease Center’s annual Celiac Disease & Continuum of Care Symposium. Healthcare providers were informed about potential new therapies and the research supporting their use, and were educated about the future of celiac disease so they can provide better care to their patients throughout the entire care continuum. The Foundation continues to fund reimbursement grants, in partnership with Proud Sponsor Schar, for the Academy of Nutrition and Dietetics Certificate of Training Program in Treating Gluten-Related Disorders to expand the pool of dietitians skilled in managing celiac disease, with 62 grants provided to date. Used by more than 25,000 physicians since 2017, the NASPGHAN Clinical Guide for Pediatric Celiac Disease, a web-based tool developed and hosted by the Celiac Disease Foundation, continues to assist physicians in the diagnosis and management of celiac disease patients.
Celiac Disease Management for Learning Environments Training Program Developed in collaboration with the nation’s leading experts in celiac disease and education, this web-based instruction and companion guide for schools, parents, and caregivers provides training on how to implement standardized accommodations required by the Americans with Disabilities Act, based upon what is medically and psychologically necessary for children with celiac disease to succeed at school.
Student Ambassadors and Team Gluten-Free The Foundation’s grassroots volunteers play a critical role in making our work possible. Our Student Ambassadors came together during May Celiac Awareness Month for Celiac Strong Day with 65 schools across the country participating in celiac disease education activities and enjoying gluten-free snacks provided by Proud Sponsor Crunchmaster. Team Gluten-Free participants are dedicated to educating their communities about the seriousness of celiac disease, and to raising critical funds for research. More than 2,000 supporters with celiac disease, their loved ones, and our sponsors, rallied to make the 2021 CDF Turkey Trot Virtual Cross-Country Challenge a phenomenal success by raising more than $200,000 to support the Foundation’s research efforts.