Study of Enzyme Supplements to Treat Celiac Disease

Study Overview
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Brief Summary
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The purpose of this study is to examine whether a cocktail of two common food-grade enzyme supplements leads to decrease of serum activity markers in celiac disease patients insufficiently treated by previous gluten exclusion.

Detailed Description
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Celiac disease is genetically determined abnormal immune response to gluten, a component of wheat, rye and barley proteins that cause damage to the villous structure in the small bowel. The active disease is characterized by the induction of gluten-dependent autoantibodies to transglutaminase type-2, which are sensitive and specific non-invasive markers of gluten-sensitivity. Gluten-free diet normally leads to clearance of antibodies from serum in 6-12 months. Persistent seropositivity is a problem in patients who only incompletely exclude gluten or frequently transgress the diet. In such cases, damage of the small bowel may persist and complications may occur at higher frequency. The central hypothesis to be tested is that enzyme treatment designed to degrade a certain amount of gluten before absorption in the gastrointestinal tract will lead to a clinically meaningful decrease in auto-antibody levels in these patients.

Official Title
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Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity

Conditions
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Celiac Disease, Dermatitis Herpetiformis

Intervention / Treatment
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* Drug: STAN1
* Drug: Placebo enzyme
* Drug: STAN1+gluten


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Celiac disease diagnosed by small intestinal biopsy More than 12 months elapsed since initial diagnosis and start of the dietary treatment Evidence for ongoing active disease as verified by seropositivity or dermatitis herpetiformis rash Subject agrees to follow a gluten-free diet Exclusion Criteria: Other gastrointestinal or hepatic disease besides celiac disease Selective IgA deficiency Use of dapsone or diaphenylsulfone Pregnancy and breast-feeding

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enzyme treatment<br>Enzyme for 12 weeks | Drug: STAN1<br>* 3-4 capsules/day at meals<br>|
| Placebo Comparator: Placebo control<br>Placebo enzyme for 12 weeks | Drug: Placebo enzyme<br>* 3-4 capsules/day at meals<br>|
| Experimental: Enzyme + gluten<br>Enzyme and 500 mg gluten b.i.d. for 12 weeks | Drug: STAN1+gluten<br>* 3-4 capsules/day at meals plus 500 mg gluten b.i.d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative seroconversion or drop of at least two dilution steps in the EMA test |  | 12 weeks | 
| Negative conversion for celiac antibodies in the blood by the rapid test |  | 12 weeks | 
| Change in symptoms or rash (if any) |  | 12 weeks | 
| Favorable changes in morphometry in small bowel biopsy specimens |  | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celiac disease, transglutaminase antibody