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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzyme treatment | Experimental | Enzyme for 12 weeks |
|
| Placebo control | Placebo Comparator | Placebo enzyme for 12 weeks |
|
| Enzyme + gluten | Experimental | Enzyme and 500 mg gluten b.i.d. for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAN1 | Drug | 3-4 capsules/day at meals |
| |
| Placebo enzyme |
| Measure | Description | Time Frame |
|---|---|---|
| Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA | 12 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilma Korponay-Szabo, M.D., Ph.D. | Heim Pal Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heim Pal Children's Hospital | Budapest | 1089 | Hungary | |||
| University of Debrecen |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D003874 | Dermatitis Herpetiformis |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
3-4 capsules/day at meals |
|
| STAN1+gluten | Drug | 3-4 capsules/day at meals plus 500 mg gluten b.i.d |
|
| Change in symptoms or rash (if any) |
| 12 weeks |
| Favorable changes in morphometry in small bowel biopsy specimens | 28 weeks |
| Debrecen |
| H-4032 |
| Hungary |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |