Effect of Aspergillus Niger Prolyl Endoprotease (AN-PEP) Enzyme on the Effects of Gluten Ingestion in Patients With Coeliac Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Celiac Disease |
Dietary Supplement: Aspergillus niger prolyl endoprotease Dietary Supplement: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study on The Effectiveness of Oral Administration of Prolyl Endoprotease for Gluten Detoxification as a Means to Treat Coeliac Disease |
- Histopathological changes according to the Modified Marsh criteria [ Time Frame: One week before start, and 2 and 6 weeks after start ] [ Designated as safety issue: No ]
- The presence of coeliac disease specific antibodies (EMA, tTGA, gliadin) [ Time Frame: One week before start, and 2 and 6 weeks after start ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Immunophenotype of lymphocytes isolated from biopsies [ Time Frame: One week before start, and 2 and 6 weeks after start ] [ Designated as safety issue: No ]
- Clinical symptoms after gluten intake with and without AN-PEP [ Time Frame: One week before start, and 2 and 6 weeks after start ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 14 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ANPEP
Aspergillus niger prolyl endoprotease (AN-PEP), a microbial-derived prolyl endoprotease which cleaves gluten
|
Dietary Supplement: Aspergillus niger prolyl endoprotease
160 PPU daily for 2 weeks
Other Name: AN-PEP
|
| Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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:
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00810654
| Netherlands | |
| VU University Medical Center | |
| Amsterdam, Netherlands, 1081 HV | |
| Principal Investigator: | Greetje J Tack, MD | VU University Medical Center |
More Information
No publications provided by VU University Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | C.J.Mulder, VU University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00810654 History of Changes |
| Other Study ID Numbers: | RD.0601.54, NTR1281 |
| Study First Received: | December 17, 2008 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Netherlands: Independent Ethics Committee |
Keywords provided by VU University Medical Center:
|
Celiac disease Coeliac disease treatment |
AN-PEP prolyl endoprotease gluten |
Additional relevant MeSH terms:
|
Celiac Disease Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Malabsorption Syndromes Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015