Prospective study of clinical and histological safety of pure and uncontaminated Canadian oats in the management of celiac disease

Background: Pure oats are safe for most patients with celiac disease, but concerns regarding contamination by other grains limit their consumption. The Canadian Celiac Association recently released guidelines governing the production of pure oats. The objective was to test the safety of a product manufactured under these guidelines. Methods: Fifteen adults with established, biopsy‐confirmed celiac disease of ≥1 year duration were challenged with 350 g/wk of pure oats for 12 weeks. Symptom scores, weight, hemoglobin, ferritin, albumin, and tissue transglutaminase (tTG) were assessed at weeks 0, 6, and 12. Duodenal biopsies were obtained before and after oat challenge and assessed based on the modified Marsh–Oberhuber score. Compliance with a gluten‐free diet was monitored with random food diaries. Results: Fifteen patients completed the study and were analyzed in intention‐to‐treat and per‐protocol analyses. There were no significant changes in symptom scores, weight, hemoglobin, ferritin, or albumin during oat consumption. The tTG remained negative in all patients, and the histology scores did not significantly change during oat challenge. The only relapse occurred in a patient who became noncompliant with her gluten‐free diet. Conclusion: The findings support the safety of pure, uncontaminated oats manufactured under Canadian Celiac Association guidelines for patients with celiac disease.