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

World Journal of Gastroenterology 2013年第35期19卷 5837-5847页

作者： Greetje J Tack Jolanda MW van de Water Maaike J Bruins Engelina MC Kooy-Winkelaar Jeroen van Bergen Petra Bonnet Anita CE Vreugdenhil Ilma Korponay-Szabo Luppo Edens B Mary E von Blomberg Marco WJ Schreurs Chris J Mulder frits koning Department of Gastroenterology and Hepatology VU University Medical Centre DSM Biotechnology Centre Department of Immunohematology and Blood Transfusion Leiden University Medical Centre Department of Pathology VU University Medical Centre Department of Paediatrics University Hospital Maastricht Department of Paediatrics University of Debrecen Paediatric Research Centre University of Tampere

AIM:To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease(AN-PEP)to mitigate the im-munogenic effects of gluten in celiac ***: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 orⅠwere *** 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 baseline included complaints,quality-of-life,serum antibodies,immunophenotyping of T-cells and duodenal mucosa ***,serum and quality of life questionnaires were collected during and after the safety,washout and efficacy *** biopsies were collected after the safety phase and after the efficacy phase.A change in histological evaluation according to the modified Marsh classification was the primary ***:In total,16 adults were enrolled in the *** serious adverse events occurred during the trial and no patients withdrew during 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 *** 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 groups were *** the efficacy phase,neither the placebo nor the AN-PEP group developed significant antibody *** IgA-EM concentrations remained negative in both *** patients were excluded from entering the efficacy phase as their mucosa showed an increase oftwo Marsh steps a

关键词： Celiac disease Gluten Enzyme Prolyl endoprotease Aspergillus niger prolyl endoprotease Treatment Adverse events efficacy IgA-tTG intestinal deposits

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