Celiac Disease Awareness Month is a time to raise awareness about a condition that affects millions of people worldwide and the need for better research and treatment options. Celiac disease currently has no approved cure — and for those living with it, that absence is often felt in everyday life.
As Aiden Wolfram of the Beyond Celiac community shared, “A cure would make life a lot more convenient. I wouldn’t have to plan every meal, double-check ingredients, or worry about cross-contamination. It would also make social life easier… It would take a lot of pressure off the small decisions I have to think about every day.”
Experiences like these highlight why continued research and clinical trials are so important. But finding reliable information and relevant trials can still feel overwhelming. At TrialX, we aim to make that process simpler by helping patients explore clinical trials in a more accessible and patient-friendly way. Through our ongoing efforts, including collaborations with organizations such as Beyond Celiac, we continue working toward improving awareness and access to research opportunities for the celiac community.
In this blog, we’re highlighting 5 active clinical trials exploring new approaches for celiac disease.
1. A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Sponsor: Nielsen Fernandez-Becker
What It’s Testing and Why It Matters
Diagnosing celiac disease often involves blood tests and an endoscopy, but researchers are continuing to explore ways to better identify and understand intestinal damage linked to the condition. This early-stage Phase 1 study is evaluating HB-2121, an investigational diagnostic drug designed to interact with the small intestine in people with suspected celiac disease.
Participants will receive a single oral dose of HB-2121 before undergoing their scheduled endoscopy procedure. Researchers will then study how the drug behaves in the body, examine intestinal biopsy samples, and monitor participants for side effects over a 30-day period.
Why This Study Stands Out
Rather than focusing on symptom management or immune suppression, this study is centered on improving how celiac disease may eventually be detected and evaluated. Researchers are using advanced imaging and tissue analysis techniques to better understand changes happening inside the small intestine after exposure to HB-2121. Because this is a first-in-patient study, it also represents an early step in exploring whether new diagnostic approaches could make identifying disease activity more precise in the future.
What It Could Mean for Patients
Many people with celiac disease experience delays in diagnosis or uncertainty during the testing process. Research into new diagnostic tools may help improve how clinicians detect intestinal inflammation and assess disease activity over time. While HB-2121 is still in very early development, studies like this help build the scientific understanding needed to create more accurate and patient-friendly approaches to celiac care.
Location
The study is recruiting at Stanford Medicine Clinical and Translational Research Unit
Explore full study details and participation information here.
2. CDGEMM Study: Understanding How Genetics, Environment, and the Gut Microbiome Influence Celiac Disease Risk
Sponsor: Massachusetts General Hospital
What It’s Testing and Why It Matters
The CDGEMM study follows infants who have a close family member with celiac disease to better understand why some children develop the condition while others do not. Researchers are examining how genetics, early-life environmental exposures, gut bacteria, diet, and metabolic patterns may work together in the development of celiac disease.
The study tracks children from infancy through early childhood, collecting information such as feeding patterns, antibiotic exposure, illnesses, growth, stool samples, and blood samples over time.
Why This Study Stands Out
Rather than focusing on a single treatment or medication, this research takes a broader approach to understanding celiac disease before it develops. Researchers are studying multiple factors at once — including the microbiome, immune markers, and environmental influences — to identify early patterns linked to loss of gluten tolerance. The long-term goal is to improve prediction, earlier detection, and possibly prevention strategies for children at higher risk of developing celiac disease.
What It Could Mean for Patients
For families with a history of celiac disease, studies like CDGEMM may help researchers better understand:
- Why does celiac disease develop differently from person to person
- Whether early-life factors influence future disease risk
- How doctors may eventually identify at-risk children earlier
Location
Recruiting in Boston, Massachusetts, USA, and Rome, Italy.
Explore full study details and participation information here.
3.Tissue Repository Study Supporting Future Research in Celiac Disease and Other Chronic Conditions
Sponsor: Sanguine Biosciences
What It’s Testing and Why It Matters
This observational study is collecting biospecimens, including blood and other health-related samples, from people living with a wide range of conditions, including celiac disease. Alongside these samples, researchers are also gathering associated medical and clinical information to support future biomedical research.
The goal is to build a large tissue repository that approved researchers can use to better understand diseases, identify biomarkers, and support the development of future diagnostics and treatments.
Why This Study Stands Out
While this study is not testing a new treatment directly, it plays an important role in advancing long-term research. Access to high-quality biospecimens and patient data can help researchers study how diseases develop, how patients respond differently to treatment, and where new therapeutic opportunities may exist. For conditions like celiac disease, repositories like this may support future discoveries related to immune responses, disease progression, and personalized medicine approaches.
What It Could Mean for Patients
Studies focused on biospecimen collection help create the foundation for future medical research. Participation may contribute to:
- Better understanding of complex immune-related conditions like celiac disease
- Development of improved diagnostic tools and research models
- Future treatment and biomarker discovery efforts
This type of research also helps ensure scientists have access to diverse patient data needed for more representative studies.
Location
Recruiting in Waltham, Massachusetts, USA.
View participation information here.
4. Study Exploring Disease-Reactive T Cells in Autoimmune Conditions, including Celiac Disease
Sponsor: TScan Therapeutics, Inc.
What It’s Testing and Why It Matters
This observational study is collecting tissue and blood samples from people living with autoimmune diseases, including celiac disease, to better understand how disease-reactive T cells contribute to inflammation and immune system activity.
For participants with celiac disease, researchers will analyze small intestine biopsy samples and blood collected during or around the time of an endoscopy. Using advanced genomic screening technology, the study aims to identify the specific targets that activate T cells involved in autoimmune disease.
Why This Study Stands Out
Autoimmune diseases develop when the immune system mistakenly attacks the body’s own tissues, but researchers still do not fully understand which specific targets trigger these immune responses. This study focuses directly on immune cells collected from inflamed tissues rather than relying only on blood-based analysis. By studying active disease tissue, researchers hope to better identify the molecular signals driving autoimmune activity in conditions like celiac disease. The research may also support the development of future tolerogenic therapies — treatments designed to retrain the immune system instead of broadly suppressing it.
What It Could Mean for Patients
Research like this may help scientists better understand:
- Why autoimmune responses develop in celiac disease
- Which immune pathways are involved in ongoing intestinal inflammation
- How future therapies could become more targeted and personalized
Location
Recruiting at multiple sites across the United States, including California, Illinois, Kentucky, Massachusetts, Pennsylvania, Rhode Island, South Carolina, and Texas.
See full study details and eligibility information here.
5. Immune Responses to Gluten
Sponsor: Boston Children’s Hospital
What It’s Testing and Why It Matters
Even small amounts of gluten can trigger an immune reaction in people with celiac disease, but researchers are still working to better understand exactly how the body responds during those early hours after exposure. This study is examining changes in immune markers after participants consume a single dose of gluten powder.
Researchers will collect blood samples before and after gluten exposure to measure cytokines, including IL-2, which may play an important role in the body’s immune response to gluten. The study includes both people with celiac disease and healthy volunteers for comparison.
Why This Study Stands Out
One of the biggest challenges in celiac disease is identifying reliable ways to measure immune activity after gluten exposure. Studies like this may help researchers better understand why symptoms can appear so quickly and differently from person to person. The research could also contribute to future diagnostic tools and help support the development of new therapies designed to reduce or prevent immune reactions triggered by gluten.
What It Could Mean for Patients
For many people with celiac disease, accidental gluten exposure can lead to symptoms that disrupt daily life even while following a strict gluten-free diet. By studying the body’s immediate immune response, researchers hope to improve how celiac disease is monitored, diagnosed, and potentially treated in the future. The findings may also help create more precise ways to evaluate whether future therapies are working.
Location
The study is currently recruiting at two U.S. locations:
- Boston Children’s Hospital
- Children’s Hospital Colorado
Moving One Step Closer to a Cure
Every clinical trial brings researchers one step closer to better treatments, improved diagnosis, and hopefully one day, prevention or a cure. If you’re interested in exploring more celiac disease studies, visit TrialX or join the Volunteer Registry to receive updates on research opportunities that may match your profile.To stay informed, learn from patient experiences, and stay connected with the broader celiac community, organizations like Beyond Celiac, Celiac Disease Foundation, and National Celiac Association also offer valuable education, advocacy, and support resources.
