Study of Enzyme Supplements to Treat Celiac Disease

Heim Pal Children's Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Celiac Disease; Dermatitis Herpetiformis

Treatments: Drug: STAN1+gluten; Drug: STAN1; Drug: Placebo enzyme

Study type: Interventional

Funder types: Other

Identifiers

NCT00962182

HP-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 3 patient groups, including a placebo group

Enzyme treatment

Experimental group

Description:

Enzyme for 12 weeks

Treatment:

Drug: STAN1

Placebo control

Placebo Comparator group

Description:

Placebo enzyme for 12 weeks

Treatment:

Drug: Placebo enzyme

Enzyme + gluten

Experimental group

Description:

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

Treatment:

Drug: STAN1+gluten