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| Sponsor: | Heim Pal Children's Hospital |
|---|---|
| Collaborator: |
Stanford University |
| Information provided by: | Heim Pal Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00962182 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Celiac Disease Dermatitis Herpetiformis |
Drug: STAN1 Drug: Placebo enzyme Drug: STAN1+gluten |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Pre-intervention placebo phase
Placebo enzyme for 4 weeks
|
Drug: Placebo enzyme
3-4 capsules/day at meals
|
|
Experimental: Enzyme treatment
Enzyme for 12 weeks
|
Drug: STAN1
3-4 capsules/day at meals
|
|
Placebo Comparator: Placebo control
Placebo enzyme for 12 weeks
|
Drug: Placebo enzyme
3-4 capsules/day at meals
|
|
Experimental: Enzyme + gluten
Enzyme and 500 mg gluten b.i.d. for 12 weeks
|
Drug: STAN1+gluten
3-4 capsules/day at meals plus 500 mg gluten b.i.d
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ilma Korponay-Szabo, M.D., Ph.D. | +36-1-459-9192 | Ilma.Korponay-Szabo@uta.fi |
| Contact: Judit Tumpek, M.D. | +36-1-459-9100 ext 1334 | tumpek.judit@freemail.hu |
| Hungary | |
| Heim Pal Children's Hospital | Recruiting |
| Budapest, Hungary, 1089 | |
| Contact: Ilma Korponay-Szabo, PhD +36-1-459-9192 Ilma.Korponay-Szabo@uta.fi | |
| Contact: Judit Tumpek +36-1-459-9100 ext 1334 tumpek.judit@freemail.hu | |
| Principal Investigator: Ilma Korponay-Szabo, M.D., Ph.D. | |
| Sub-Investigator: Judit Tumpek, M.D. | |
| University of Debrecen | Recruiting |
| Debrecen, Hungary, H-4032 | |
| Contact: Ilma Korponay-Szabo, M.D., Ph.D. +36-52-255-603 ext 56168 Ilma.Korponay-Szabo@uta.fi | |
| Contact: Eva Nemes, M.D., Ph.D. +36-52-255-603 ext 56168 enemes@dote.hu | |
| Principal Investigator: Ilma Korponay-Szabo, M.D., Ph.D | |
| Sub-Investigator: Judit Tumpek, M.D. | |
| Sub-Investigator: Eva Nemes, M.D., Ph.D. | |
| Study Director: | Ilma Korponay-Szabo, M.D., Ph.D. | Heim Pal Children's Hospital |
More Information
| Responsible Party: | Ilma Korponay-Szabo, associate professor, Heim Pal Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00962182 History of Changes |
| Other Study ID Numbers: | HP-03 |
| Study First Received: | August 18, 2009 |
| Last Updated: | August 18, 2009 |
| Health Authority: | Hungary: National Institute for Food and Nutrition Science |
|
celiac disease transglutaminase antibody |
|
Celiac Disease Dermatitis Dermatitis Herpetiformis Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Metabolic Diseases Skin Diseases Skin Diseases, Vesiculobullous Autoimmune Diseases Immune System Diseases |