biostudies-literatureUnknown19(35)Tack GJ<h4>Aim</h4>To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients.<h4>Methods</h4>Patients with initial diagnosis of celiac disease as confirmed by positive serology with subtotal or total villous atrophy on duodenal biopsies who adhere to a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. In a randomised double-blind placebo-controlled pilot study, patients consumed toast (approximately 7 g/d gluten) with AN-PEP for 2 wk (safety phase). After a 2-wk washout period with adherence of the usual GFD, 14 patients were randomised to gluten intake with either AN-PEP or placebo for 2 wk (efficacy phase). Measurements at baseWorld journal of gastroenterology5837-47https://www.ebi.ac.uk/biostudies/studies/S-EPMC3793137biostudies-literatureConsumption of gluten with gluten-degrading enzyme by celiac patients: a pilot-study.PMC3793137Edens LKoning Fvan Bergen JBruins MJKorponay-Szabo ISchreurs MWKooy-Winkelaar EMvan de Water JMMulder CJBonnet PVreugdenhil ACTack GJvon Blomberg BMfalseConsumption of gluten with gluten-degrading enzyme by celiac patients: a pilot-study.<h4>Aim</h4>To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients.<h4>Methods</h4>Patients with initial diagnosis of celiac disease as confirmed by positive serology with subtotal or total villous atrophy on duodenal biopsies who adhere to a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. In a randomised double-blind placebo-controlled pilot study, patients consumed toast (approximately 7 g/d gluten) with AN-PEP for 2 wk (safety phase). After a 2-wk washout period with adherence of the usual GFD, 14 patients were randomised to gluten intake with either AN-PEP or placebo for 2 wk (efficacy phase). Measurements at base2013-01-01T00:00:00Z2013 Sep2025-04-04T12:56:07.341Z2019-03-27T01:17:00ZS-EPMC37931372412432810.3748/wjg.v19.i35.5837