Randomized clinical trial: Effective gluten degradation by Aspergillus niger-derived enzyme in a complex meal setting.

Abstract:

:The Aspergillus niger-derived prolyl endoprotease (AN-PEP) has previously been shown to degrade gluten in healthy subjects when added to an intragastrically infused meal. The current study investigated the efficacy of AN-PEP in a physiological meal setting. In this randomized placebo-controlled crossover study, 18 gluten-sensitive subjects consumed a porridge containing 0.5 g gluten together with two tablets either containing a high or low dose of AN-PEP, or placebo. Gastric and duodenal content was sampled over 180 minutes, and areas under the curve of gluten concentrations were calculated. The primary outcome, i.e. success rate of high dose AN-PEP defined as at least 50% gluten degradation compared to placebo in the duodenum, was achieved in 10 of 13 comparisons. In the stomach, gluten levels were reduced from 176.9 (median, interquartile range 73.5-357.8) to 22.0 (10.6-50.8, p = 0.001) in the high dose and to 25.4 μg × min/ml (16.4-43.7, p = 0.001) in the low dose. In the duodenum, gluten levels were reduced from 14.1 (8.3-124.7) in the placebo to 6.3 (3.5-19.8, p = 0.019) in the high dose and to 7.4 μg × min/ml in the low dose (3.8-12.0, p = 0.015). Thus even in a physiological meal setting, AN-PEP significantly degraded most gluten in the stomach before it entered the duodenum.

journal_name

Sci Rep

journal_title

Scientific reports

authors

König J,Holster S,Bruins MJ,Brummer RJ

doi

10.1038/s41598-017-13587-7

subject

Has Abstract

pub_date

2017-10-12 00:00:00

pages

13100

issue

1

issn

2045-2322

pii

10.1038/s41598-017-13587-7

journal_volume

7

pub_type

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