Celiac disease is an autoimmune condition in which ingestion of gluten triggers an immune attack on the small intestine, causing villous atrophy, malabsorption, and symptoms including diarrhea, fatigue, and weight loss. The only current treatment is strict lifelong gluten avoidance, which is difficult to maintain and leaves many patients with persistent intestinal damage and symptoms despite adherence.
What's actually going on in research
A gluten-free diet resolves symptoms in most patients but mucosal healing is often incomplete, and inadvertent gluten exposure is common. Trials are testing enzyme therapies that break down gluten before it triggers an immune response, immune tolerance induction, and drugs targeting the inflammatory cascade including IL-15 and TG2 transglutaminase inhibitors. Refractory celiac disease, a rare but serious form that does not respond to dietary restriction, is being addressed with immunosuppressants and monoclonal antibodies.
Gluten-degrading enzymes
Latiglutenase and other oral enzyme therapies that digest gluten in the stomach before it reaches the small intestine are in trials to reduce the immune impact of accidental gluten exposure.
IL-15 pathway blockade
AMG 714 and other anti-IL-15 antibodies are being studied for refractory celiac disease and for reducing intestinal inflammation in patients with persistent damage despite a strict gluten-free diet.
Immune tolerance induction
Nexvax2 and newer peptide-based desensitization vaccines are in trials aiming to train the immune system to tolerate gluten peptides, potentially allowing treated patients to eat a less restricted diet.
What to know before you search
Eligibility depends on celiac diagnosis confirmation, biopsy findings, degree of dietary adherence, and for refractory celiac trials, prior treatment history.
What types of trials are currently open
- Enzyme therapy trials — Testing oral gluten-degrading enzymes that reduce immune activation from accidental gluten exposure.
- Anti-inflammatory drug trials — Evaluating IL-15 blockers and other targeted drugs for mucosal healing and refractory disease.
- Tolerance vaccine trials — Studying peptide-based vaccination approaches to induce immune tolerance to gluten.
- Refractory celiac trials — Testing immunosuppressants and biologics for the rare form of celiac disease that does not respond to gluten restriction.
- Diagnostic accuracy trials — Comparing serology, biopsy scoring, and novel biomarkers to improve diagnostic precision.
Recently added Celiac Disease trials
Receive targeted radiation to relieve cancer-related abdominal pain
This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery. In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel. Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.
Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease
The goal of this clinical trial is to learn if omega-3 fatty acid supplements (n-3 PUFAs) can help reduce inflammation and promote intestinal healing in adults newly diagnosed with celiac disease (CD). Celiac disease is a chronic autoimmune disorder where eating gluten-a protein found in wheat-triggers an immune response that damages the lining of the small intestine. This damage causes inflammation and symptoms such as stomach pain, diarrhea, and nutrient absorption problems. The only current treatment is a strict gluten-free diet (GFD), which can help most people recover, but some continue to have inflammation and symptoms. This study will test whether supplementing with 2.4 grams of n-3 PUFAs daily for three months, alongside starting a gluten-free diet, reduces inflammation in the blood and intestine more effectively than the gluten-free diet alone. Participants will: Be adults recently diagnosed with celiac disease who have not yet started a gluten-free diet Be randomly assigned to one of two groups: One group will receive omega-3 supplements containing 2,400 mg of n-3 PUFAs daily (2,000 mg DHA and 400 mg EPA) The other group will receive a placebo (a pill with no active ingredients that looks like the supplement) Take the assigned supplement every day for 3 months while following a supervised gluten-free diet Visit the clinic regularly for checkups, blood tests, and monitoring of symptoms and diet adherence Provide blood and stool samples before and after the intervention to measure inflammation and changes in gut bacteria A subgroup of participants will undergo small intestinal biopsies to assess local inflammation and healing The study aims to answer these main questions: Does omega-3 supplementation change the fatty acid composition in blood cells? Does it reduce markers of inflammation in the blood and small intestine? Does it improve the diversity and health of gut bacteria in the intestine? Does it help the small intestine heal faster compared to diet alone? Researchers will measure inflammation by analyzing immune signaling pathways, oxidative stress markers, and antioxidant activity in blood cells. They will also study the composition of the gut microbiota and its metabolites. These detailed measurements will help understand how omega-3 fatty acids may influence the immune response and gut health in celiac disease. This is a randomized, double-blind, placebo-controlled crossover study. This means participants and researchers will not know who receives the supplement or placebo during the study period, reducing bias and improving the reliability of the results. This study is important because it could offer a simple, additional treatment to improve recovery in celiac disease beyond the gluten-free diet. If omega-3 supplements are shown to reduce inflammation and support healing, they could become a valuable part of managing this chronic condition. Participation is voluntary, and participants can leave the study at any time without affecting their medical care. All participants will be closely monitored to ensure safety throughout the study.
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