2015
DOI: 10.1111/apt.13266
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Randomised clinical study: Aspergillus niger‐derived enzyme digests gluten in the stomach of healthy volunteers

Abstract: SummaryBackground Aspergillus niger prolyl endoprotease (AN‐PEP) efficiently degrades gluten molecules into non‐immunogenic peptides in vitro.AimTo assess the efficacy of AN‐PEP on gluten degradation in a low and high calorie meal in healthy subjects.MethodsIn this randomised, double‐blind, placebo‐controlled, cross‐over study 12 healthy volunteers attended to four test days. A liquid low or high calorie meal (4 g gluten) with AN‐PEP or placebo was administered into the stomach. Via a triple‐lumen catheter gas… Show more

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Cited by 61 publications
(45 citation statements)
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“…For instance, the use of prolyl endopeptidase (PEP) enzymes as a tool to detoxify gluten fragments and cleave peptides at proline or glutamine residues has been proposed. ALV003 and AN‐PEP from Aspergillus niger (AN‐PEP) are currently under clinical investigation and preliminary results demonstrated that they are well tolerated by CD patients . However, the major problem related to their use is connected with their stability in acidic gastric conditions and their efficiency in gluten degradation.…”
Section: Discussionmentioning
confidence: 99%
“…For instance, the use of prolyl endopeptidase (PEP) enzymes as a tool to detoxify gluten fragments and cleave peptides at proline or glutamine residues has been proposed. ALV003 and AN‐PEP from Aspergillus niger (AN‐PEP) are currently under clinical investigation and preliminary results demonstrated that they are well tolerated by CD patients . However, the major problem related to their use is connected with their stability in acidic gastric conditions and their efficiency in gluten degradation.…”
Section: Discussionmentioning
confidence: 99%
“…This non-validated questionnaire has been described before by Salden et al . [17]. Feelings of abdominal discomfort, abdominal pain, abdominal distension, constipation, diarrhea, flatulence, eructation, nausea and total discomfort were assessed by scores from 1 (no symptoms) to 5 (pronounced symptoms).…”
Section: Methodsmentioning
confidence: 99%
“…Consequently, it is capable of degrading gluten in the stomach compartment both in vitro and in vivo and it has been found to exert no harmful effects in patients and healthy human volunteers [32,[35][36][37] . The enzyme is expected to reach the market as an over-the-counter product in 2015.…”
Section: Enzymatic Gluten Degradationmentioning
confidence: 99%