Interested in new trials?
Get alerts for new trials in your area by subscribing now
Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain
What is celiac disease?
Celiac disease is an autoimmune reaction to gluten, the protein found in wheat, barley, and rye. In people who carry the genes HLA-DQ2 or HLA-DQ8, gluten triggers the immune system to damage the villi, the tiny finger like projections that line the small intestine and absorb nutrients. Flattened villi mean nutrients pass through undigested, which explains why the disease shows up not only as digestive symptoms but as iron deficiency anemia, osteoporosis, infertility, mouth ulcers, an itchy blistering rash called dermatitis herpetiformis, and in children delayed puberty and poor growth. Some people have no digestive symptoms at all, which is one reason diagnosis is so often missed or delayed for years.
Genetics set the stage but do not decide the outcome: roughly 30 to 40 percent of people carry HLA-DQ2 or DQ8, yet only about 1 percent develop celiac disease, so something else triggers it. Having a first degree relative with celiac disease raises the risk to about 1 in 10, which is why family members are screened, and the disease is more common in people with type 1 diabetes, autoimmune thyroid disease, and Down syndrome. Celiac disease is also frequently confused with two other conditions: a wheat allergy, which is an allergic reaction that can cause hives or breathing problems, and non celiac gluten sensitivity, in which gluten causes symptoms without the intestinal damage or the antibodies. Only celiac disease damages the intestine, and telling them apart requires testing before any gluten free diet begins. Symptoms also overlap heavily with irritable bowel syndrome and Crohn's disease.
Why there is no celiac disease medication yet
Every other common autoimmune disease has drug treatments. Celiac disease does not, and the reason is partly that an effective alternative already exists: removing gluten stops the immune attack. But the diet is an imperfect treatment. Studies find that many adults who follow it strictly still have intestinal damage on repeat biopsy, accidental gluten exposure is routine in restaurants and packaged food, and the diet is expensive and socially isolating. That gap is what current trials address, and they take several different approaches.
Some aim to break gluten down before it reaches the immune system, using enzymes taken with meals. Some block the immune reaction itself, targeting the enzyme tissue transglutaminase or the immune signals that drive the damage. A newer group tries to retrain the immune system to tolerate gluten, the way allergy desensitization works, so that the underlying disease is switched off rather than avoided. Others are designed to protect people from accidental exposure rather than to allow a normal diet. None of these is approved, several have failed in late stage testing over the past decade, and the trials listed here are how the remaining candidates are being tested. A medicine, if one is approved, would most likely be used alongside the gluten free diet rather than replacing it.
How do you test for celiac disease?
It starts with a blood test for tissue transglutaminase antibodies, usually confirmed by an upper endoscopy with biopsies of the small intestine. Both require that you are still eating gluten: starting a gluten free diet first can make the tests negative even if you have the disease. Genetic testing for HLA-DQ2 and DQ8 can rule celiac disease out but cannot confirm it, since many people carry those genes without developing it.
Types of celiac disease clinical trials
Immune tolerance trials. Treatments designed to retrain the immune system so it stops reacting to gluten, the approach closest to addressing the cause rather than the exposure.
Gluten degrading enzyme trials. Enzymes taken with food that break gluten into fragments the immune system does not recognize, aimed mainly at accidental exposure.
Immune blocking drug trials. Antibodies and small molecules that interrupt the immune pathway between gluten and intestinal damage, several of them borrowed from other autoimmune diseases.
Gluten challenge studies. Trials in which participants eat a measured amount of gluten under medical supervision so researchers can see whether a treatment prevents the immune response. These require stopping the gluten free diet temporarily and are explained in detail during consent.
Diagnosis and healing studies. Research on blood tests and biopsies that could confirm celiac disease without a gluten challenge, and studies tracking how and whether the intestine heals on the diet.
Nutrition and quality of life studies. Research on nutrient deficiencies such as zinc and iron, on the nutritional quality of gluten free diets in children, and on the practical and psychological burden of the diet.
Celiac disease is often mistaken for irritable bowel syndrome or Crohn's disease, and it occurs more often in people with type 1 diabetes. New to research? Our guides explain how eligibility criteria work.
Who can participate in celiac disease clinical trials?
Most treatment trials enroll adults with celiac disease confirmed by blood antibody tests and, in most cases, an intestinal biopsy; a self diagnosis or a gluten free diet started without testing is usually not enough, and some studies require the original diagnostic records. Many require that you have been on a gluten free diet for at least 6 to 12 months, so that the intestine has had time to heal before the study begins. Trials that involve a gluten challenge exclude people with a history of severe reactions and explain the amount and duration in advance. Pediatric studies enroll children, often around nutrition and growth. Diagnostic studies may enroll people who are still eating gluten and are being evaluated, and some genetic and family studies enroll relatives without the disease. Eligibility always varies by study.
Do celiac disease trial participants get paid?
Some studies offer compensation for time and travel, and study related care, including the study treatment, visits, and any endoscopies the protocol requires, is typically provided at no cost to participants. Gluten challenge studies, which ask more of participants, often compensate accordingly. Compensation varies by trial and is always described during the informed consent process before you agree to anything.
Curious whether clinical trials pay participants? Here's how compensation actually works.
How to enroll in a celiac disease clinical trial
Identify your trial. Use the filters. Titles usually say whether the study tests a treatment, involves a gluten challenge, or is observational. Check whether it is for adults or children.
Select your preferred location. Enter your city or state. Treatment trials run at gastroenterology centers and often require endoscopy visits, so distance matters; some nutrition and quality of life studies run partly online.
Explore study details. Click "Learn More" for eligibility, including how your diagnosis must be documented, how long you must have been gluten free, and whether a biopsy or gluten challenge is part of the study.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: how and when you were diagnosed, including biopsy results if you have them, how long you have been on a gluten free diet and how strictly, and any related conditions such as type 1 diabetes or thyroid disease.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step. Do not change your diet in preparation for a study unless a study doctor asks you to.