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One of the main obstacles to successfully managing the gluten-free diet (GFD) and conducting clinical trials in celiac disease is the lack of an objective assay to measure gluten consumption. Celiac patients have no reliable method to determine whether the small amounts of gluten in gluten-free foods or in prepared meals outside of their homes are above a threshold that triggers their disease (50 milligrams per day according to Catassi and collaborators). The current situation is analogous to trying to control diabetes without a method to assess glucose levels.
To address this need, a novel method has been developed in Europe to assess gluten consumption by quantifying gluten in stools. iVYLISA GIP is a gluten stool test developed by Biomedal SL (Seville, Spain). Celimmune will utilize this method in clinical trials.