CompletedNCT00810654Updated Jan 19, 2011

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

A Phase 1/2 interventional study of Aspergillus niger prolyl endoprotease and Placebo in Celiac Disease, sponsored by Amsterdam UMC, location VUmc. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-01-19.

Sponsored by Amsterdam UMC, location VUmc · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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-administration of such an enzyme, a prolyl endoprotease derived from the food grade organism Aspergillis niger (AN-PEP), is capable of detoxifying 8 grams of gluten in a commercial food product.

Read the 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 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 given a food product containing 8 g of wheat protein, to which AN-PEP is added, once daily for 14 d.

Period 2: Wash-out period of 14 d. During this period, patients will consume a gluten-free diet.

Period 3: Patients who are negative for coeliac disease symptoms during the 1st period will be randomized across two groups. Both groups receive a food product containing 8 g of wheat protein once daily for 14 d. One group receives additional AN-PEP with the gluten meal whereas the other group receives the placebo.

Patients will visit the outpatient clinic five times; one visit before the start of the study, a visit during and at the end of the first period, and a visit during and at the end of the third period. During three of the visits, spike-biopsies are taken from the duodenum by oesophago-gastro-duodenoscopy. Blood samples are taken during all of the five visits. Patients will also fill in a quality of life questionnaire at the start and the end of the first and third period.

Conditions studied

Celiac Disease

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Celiac Disease 333

Keywords

Celiac disease
Coeliac disease
treatment
AN-PEP
prolyl endoprotease
gluten

In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.

This study's planned enrollment of 14 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 14 participants (estimated)

Study arms

Experimental
ANPEP
Aspergillus niger prolyl endoprotease (AN-PEP), a microbial-derived prolyl endoprotease which cleaves gluten
Dietary Supplement: Aspergillus niger prolyl endoprotease
Placebo comparator
Placebo
Dietary Supplement: Placebo

Interventions

Dietary supplementAspergillus niger prolyl endoprotease
160 PPU daily for 2 weeks
Also known as: AN-PEP
Dietary supplementPlacebo
Placebo

What researchers measure

Primary outcomes

Histopathological changes according to the Modified Marsh criteria
Time frame: One week before start, and 2 and 6 weeks after start
The presence of coeliac disease specific antibodies (EMA, tTGA, gliadin)
Time frame: One week before start, and 2 and 6 weeks after start

Secondary outcomes

Presence and activity of gluten reactive Tcells isolated from biopsies and serum
Time frame: One week before start, and 2 and 6 weeks after start
Immunophenotype of lymphocytes isolated from biopsies
Time frame: One week before start, and 2 and 6 weeks after start
Clinical symptoms after gluten intake with and without AN-PEP
Time frame: One week before start, and 2 and 6 weeks after start

Study locations

1 site

VU University Medical Center
Amsterdam, 1081 HV, Netherlands

References and documents

Publications

Tack GJ, van de Water JM, Bruins MJ, Kooy-Winkelaar EM, van Bergen J, Bonnet P, Vreugdenhil AC, Korponay-Szabo I, Edens L, von Blomberg BM, Schreurs MW, Mulder CJ, Koning F. Consumption of gluten with gluten-degrading enzyme by celiac patients: a pilot-study. World J Gastroenterol. 2013 Sep 21;19(35):5837-47. doi: 10.3748/wjg.v19.i35.5837. PubMed 24124328 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00810654
Lead sponsor: Amsterdam UMC, location VUmc
Collaborators: DSM Food Specialties, Leiden University Medical Center
First posted: Dec 18, 2008
Start date: May 2008
Primary completion: May 2009
Completion: Dec 2009
Last update: Jan 19, 2011

Study contacts

Greetje J Tack, MD

principal investigator · Amsterdam UMC, location VUmc

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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