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

GJ Tack, JMW Van de Water, MJ Bruins, EMC Kooy-Winkelaar, J van Bergen, P Bonnet, ACE Vreugdenhil, I Korponay-Szabo, L Edens, BME von Blomberg, Marco Schreurs, CJ Mulder, F Koning

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

AIM: To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients. METHODS: 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. 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 usua RESULTS: In total, 16 adults were enrolled in the study. No serious adverse events occurred during the trial and no patients withdrew during the trial. The mean score for the gastrointestinal subcategory of the celiac disease quality (CDQ) was relatively high throughout the study, indicating that AN-PEP was well tolerated. In the efficacy phase, the CDQ scores of patients consuming gluten with placebo or gluten with AN-PEP did not significantly deteriorate and moreover no differences between the CONCLUSION: AN-PEP appears to be well tolerated. However, the primary endpoint was not met due to lack of clinical deterioration upon placebo, impeding an effect of AN-PEP. (C) 2013 Baishideng. All rights reserved.
Original languageUndefined/Unknown
Pages (from-to)5837-5847
Number of pages11
JournalWorld Journal of Gastroenterology
Volume19
Issue number35
DOIs
Publication statusPublished - 2013

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