Effect of Aspergillus Niger Prolyl Endoprotease (AN-PEP) Enzyme on the Effects of Gluten Ingestion in Patients With Coeliac Disease

Launched by AMSTERDAM UMC, LOCATION VUMC · Dec 17, 2008

Keywords

ClinConnect Summary

The objective of the study is to determine whether AN-PEP enzyme is effective in mitigating the effects of 8 g wheat protein ingestion in patients with celiac disease.

Fourteen patients with coeliac disease, 18-70 years old are recruited. During the first period, patients consume once daily a gluten-containing food product with the AN-PEP enzyme for 2 weeks. After a 2-week washout period (second period), patients enter the third period of this study, and are randomized to one of two groups and consume the same gluten-containing food product with AN-PEP or placebo.

Period 1: Patients are g...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of coeliac disease (Marsh III B/C) ; that means crypt hyperplasia and subtotal or total villous atrophy, while using a normal diet followed by normalisation and clinical improvement on a gluten-free diet;
• • Detectable coeliac disease specific antibodies (EMA, tTGA) at time of diagnosis.
• • A strict gluten free diet for at least 1 year and normalised villous architecture (Marsh 0/I);
• • Male and female, 18-70 years old;
• • No detectable anti-endomysium and low anti-tissue transglutaminase (\< 4 U/ml) prior to the start of the study;
• • Patient is willing to undergo all protocol related assessments and visits (including up to 3 separate oesophago-gastro-duodenoscopies with multiple biopsies taken each time from the descending duodenum);
• • Patient has read the information provided on the study and given written consent;
• • Female participants at fertile age must use adequate contraception.
• Exclusion Criteria:
• • Use of any immunoregulatory drug within the last 6 months;
• • Use of any anticoagulant drug;
• • Clinically suspected bleeding tendency;
• • Pregnancy or breast feeding;
• • Presence of any concurrent active infection;
• • IgA deficiency.