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New Treatments & Clinical Trials for Celiac Disease

Last updated September 2026Data from ClinicalTrials.gov94 active trials
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Celiac disease is an autoimmune condition where eating gluten damages the small intestine. It affects about 1 in 100 people worldwide. The only current treatment is lifelong gluten-free diet, which works well for most people but is demanding and doesn't help everyone.

What's actually going on in research

Trials are testing drugs that break down gluten before it triggers damage, therapies that block the immune attack in the intestine, and vaccines that might retrain the immune system to tolerate gluten. Some studies focus on helping people who don't improve on gluten-free diet alone, while others aim to make accidental gluten exposure less harmful.

Gluten-degrading enzymes

Pills containing enzymes that break down gluten in the stomach are in late-stage testing. They're designed to protect against accidental gluten exposure, not to replace gluten-free diet.

Immune checkpoint blockers

Drugs that interrupt the specific immune reaction to gluten are being tested. One approach blocks an enzyme called transglutaminase 2, which is central to celiac inflammation.

Therapeutic vaccines

Vaccines aim to retrain the immune system to stop treating gluten as a threat. Early trials are testing whether repeated small exposures to gluten fragments can build tolerance.

What to know before you search

Eligibility often depends on confirmed celiac diagnosis by biopsy, how long you've been on gluten-free diet, and whether symptoms are controlled.

What types of trials are currently open

  • Enzyme therapy trials — Testing pills taken with meals to break down gluten before it reaches the intestine. Most measure intestinal damage on biopsy after controlled gluten exposure.
  • Immune modulator trials — Testing drugs that block specific steps in the celiac immune reaction, often while participants continue gluten-free diet.
  • Vaccine trials — Testing injections or pills containing gluten fragments, given over months to see if the immune system learns to tolerate gluten.
  • Non-responsive celiac trials — Studies for people who still have symptoms or intestinal damage despite strict gluten-free diet.
  • Microbiome studies — Following people with celiac disease to learn how gut bacteria interact with gluten and immune responses.

Recently added Celiac Disease trials

RecruitingObservational study

Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet

Coeliac disease is a lifelong autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, barley and rye, affecting about 1% of the general population. The only currently approved treatment is a strict, lifelong gluten-free diet (GFD). Although strict adherence to a gluten-free diet leads to mucosal recovery in most patients, up to 20-30% of coeliac patients continue to experience persistent gastrointestinal symptoms (such as abdominal pain, bloating, diarrhoea or constipation). Furthermore, commercially prepared gluten-free products often contain higher amounts of fat, sugar and salt, and lower amounts of fibre, protein, folate and vitamins compared with gluten-containing equivalents. Conversely, the Mediterranean diet-rich in vegetables, fruits, legumes, fish, nuts and extra-virgin olive oil-is widely recognised for its benefits on cardiovascular, metabolic and gut health, as well as quality of life, in contrast to diets rich in highly or ultra-processed foods. This multicentre cross-sectional observational study aims to evaluate whether adult coeliac patients on a long-term strict gluten-free diet whose habitual diet more closely aligns with the Mediterranean dietary pattern are less likely to experience persistent gastrointestinal symptoms and have a better quality of life and nutritional status, and conversely whether higher consumption of highly processed foods is associated with worse symptoms, poorer quality of life and less adequate nutritional status. No dietary intervention is provided as part of the study; participants complete validated questionnaires and undergo routine anthropometric and blood assessments during a single regular outpatient follow-up visit.

Brescia, BS, Italy +6 more
RecruitingObservational study

Share blood samples to assess your diabetes risk

Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. In Italy, approximately 300,000 individuals are affected by T1D, with a prevalence of 0.5% in the general population and 0.22% in the pediatric population. The annual incidence among children is 12.26 per 100,000, with boys affected more frequently than girls (13.13 vs. 11.35 per 100,000). Alarmingly, 25-40% of pediatric patients present with diabetic ketoacidosis (DKA) at disease onset. International prospective studies, such as the Environmental Determinants of Diabetes in the Young (TEDDY) study, have demonstrated that symptoms are poor predictors of CD autoimmunity, emphasizing the need for structured population-based screening strategies. Similarly, in T1D, the appearance of disease-specific autoantibodies-such as anti-GAD, insulin autoantibodies (IAA), IA-2A, and ZnT8A-can precede the onset of clinical disease by years. Identifying these markers enables early risk stratification, timely monitoring, and potential enrollment in immunomodulatory prevention trials, including those organized by TrialNet. In this context, an observational study is being conducted at the Pediatric Department of the University of Bari. It involves the prospective screening of children (ages 1 to 18 years) with a confirmed diagnosis of celiac disease for T1D-associated autoantibodies. The study aims to enroll 600 CD patients over one year, with an anticipated 80% participation rate among eligible families.

Bari, BA, Italy
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