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
Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
Celiac disease in children is frequently associated with iron deficiency and/or iron deficiency anemia due to intestinal malabsorption and chronic inflammation. Although a gluten-free diet is the standard treatment and can restore iron balance over time, there is currently no clear evidence or consensus on the role and timing of iron supplementation in pediatric patients at diagnosis. Given the potential impact of anemia on growth and neurodevelopment, strategies that enable a faster correction of iron deficiency are clinically relevant. Sucrosomial® iron has shown improved absorption and gastrointestinal tolerability compared to conventional oral iron in adult celiac patients. This study aims to evaluate whether Sucrosomial® iron supplementation, in addition to a gluten-free diet, is more effective and safe than diet alone in achieving a faster normalization of hemoglobin and iron stores in children with newly diagnosed celiac disease. The primary objective of this randomized, double-blind, placebo-controlled, parallel-group study is to assess whether oral supplementation with Sucrosomial® iron, when added to a gluten-free diet (GFD), accelerates the normalization of iron stores and hemoglobin levels compared with GFD alone in school-age children and adolescents newly diagnosed with celiac disease presenting with hypoferritinemia and/or iron deficiency anemia. Target Study Population: Children and adolescents with celiac disease and iron deficiency or anemia due to iron deficiency. Study Duration Total study duration (per patient) will be about 6 months; total treatment duration (per patient) will be 6 months. Number of Patients: 60 planned Two typologies of patients will be included: with hypoferritinemia and with anemia due to iron deficiency. The randomization process will be stratified, so that: * 15 patients with hypoferritinemia receive active treatment and 15 patients receive placebo; * 15 patients with anemia due to iron deficiency receive active treatment and 15 patients receive placebo. The age of patients will also be considered for the randomization (to assign the correct number of product bottles).
Histomolecular Profiling in Small-Bowel Diseases
This prospective cohort study aims to establish reliable histological reference values for normal small-bowel mucosa, improve histological diagnostic quality in celiac disease, and develop an advanced molecular profile for disease diagnosis and treatment response evaluation. The study will collect duodenal biopsies from three groups: healthy controls undergoing clinically indicated gastroscopy, patients referred for primary celiac disease diagnostics, and patients with small-bowel mucosal injury unresponsive to a gluten-free diet. Patients will undergo routine clinical assessment via standard pathology review of diagnostic biopsies. Biopsies will be analyzed using digital morphometry, AI-based image analysis, RNA sequencing (transcriptomics), and intestinal organoid cultures.
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