NCT00810654

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-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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 19, 2011

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

December 17, 2008

Last Update Submit

January 18, 2011

Conditions

Celiac Disease

Keywords

Celiac diseaseCoeliac diseasetreatmentAN-PEPprolyl endoproteasegluten

Outcome Measures

Primary Outcomes (2)

  • Histopathological changes according to the Modified Marsh criteria

    One week before start, and 2 and 6 weeks after start

  • The presence of coeliac disease specific antibodies (EMA, tTGA, gliadin)

    One week before start, and 2 and 6 weeks after start

Secondary Outcomes (3)

  • Presence and activity of gluten reactive Tcells isolated from biopsies and serum

    One week before start, and 2 and 6 weeks after start

  • Immunophenotype of lymphocytes isolated from biopsies

    One week before start, and 2 and 6 weeks after start

  • Clinical symptoms after gluten intake with and without AN-PEP

    One week before start, and 2 and 6 weeks after start

Study Arms (2)

ANPEP

EXPERIMENTAL

Aspergillus niger prolyl endoprotease (AN-PEP), a microbial-derived prolyl endoprotease which cleaves gluten

Dietary Supplement: Aspergillus niger prolyl endoprotease

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Aspergillus niger prolyl endoproteaseDIETARY_SUPPLEMENT

160 PPU daily for 2 weeks

Also known as: AN-PEP
ANPEP
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24124328DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Greetje J Tack, MD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

January 19, 2011

Record last verified: 2009-05

Locations

NL(1)