Study of Enzyme Supplements to Treat Celiac Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Celiac Disease Dermatitis Herpetiformis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Enzyme treatment

Enzyme for 12 weeks

Group Type EXPERIMENTAL

STAN1

Intervention Type DRUG

3-4 capsules/day at meals

Placebo control

Placebo enzyme for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo enzyme

Intervention Type DRUG

3-4 capsules/day at meals

Enzyme + gluten

Enzyme and 500 mg gluten b.i.d. for 12 weeks

Group Type EXPERIMENTAL

STAN1+gluten

Intervention Type DRUG

3-4 capsules/day at meals plus 500 mg gluten b.i.d

Interventions

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STAN1

3-4 capsules/day at meals

Intervention Type DRUG

Placebo enzyme

3-4 capsules/day at meals

Intervention Type DRUG

STAN1+gluten

3-4 capsules/day at meals plus 500 mg gluten b.i.d

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No