Celiac Disease, Dermatitis Herpetiformis
Conditions
Keywords
celiac disease, transglutaminase antibody
Brief summary
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
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.
Interventions
DRUGSTAN1
3-4 capsules/day at meals
DRUGPlacebo enzyme
3-4 capsules/day at meals
DRUGSTAN1+gluten
3-4 capsules/day at meals plus 500 mg gluten b.i.d
Sponsors
Stanford University
Heim Pal Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA | 12 weeks |
Secondary
| Measure | 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 |
Countries
Hungary
Outcome results
None listed