Status:
COMPLETED
Effect of Aspergillus Niger Prolyl Endoprotease (AN-PEP) Enzyme on the Effects of Gluten Ingestion in Patients With Coeliac Disease
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
DSM Food Specialties
Leiden University Medical Center
Conditions:
Celiac Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Oral supplementation with enzymes that can cut gluten has been suggested as a potential treatment modality for coeliac disease. In the present study the investigators wish to determine if co-administr...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00810654
Start Date
May 1 2008
End Date
December 1 2009
Last Update
January 19 2011
Active Locations (1)
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1
VU University Medical Center
Amsterdam, Netherlands, 1081 HV