Celiac Disease Clinical Trial
Official title:
Study on The Effectiveness of Oral Administration of Prolyl Endoprotease for Gluten Detoxification as a Means to Treat Coeliac Disease
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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