Consumption of gluten with gluten-degrading enzyme by celiac patients: A pilot-study

Figure 1 Study design and flowchart. In the safety phase, 16 patients daily consumed 5 pieces of toast with Aspergillus niger prolyl endoprotease (AN-PEP) for 2 wk while continuing their gluten-free diet (GFD). Two patients deteriorated on Marsh scores and were excluded. After a 2-wk wash-out period during which the patients continued their usual GFD, the remainder of 14 patients were randomized to the efficacy phase to receive 2 wk of toast with either AN-PEP or placebo while continuing their GFD. CDQ: Celiac disease quality.