The AN-PEP, an Aspergillus niger derived endopeptidase, has been developed aiming to produce
a complete luminal detoxification of gluten. If AN-PEP is able to produce a complete luminal
digestion of gluten in the context of the real life of celiac disease (CeD) patients is
unknown. Hypothetically, AN-PEP effect could be detected by the reduction in the excretion of
GIP in stool and urine.
The objective of this study is to establish the effect of the daily administration of AN-PEP
compared to placebo on GIP excretion in an interventional, prospective, randomized,
comparative, double-blind study in conditions mimicking the real-life of CeD treated
patients. The study consists in a four-week GFD stabilization period followed by a four-week
study period with patients randomized to receive active AN-PEP or placebo in a blindly
manner.