Status:
COMPLETED
Study of Enzyme Supplements to Treat Celiac Disease
Lead Sponsor:
Heim Pal Children's Hospital
Collaborating Sponsors:
Stanford University
Conditions:
Celiac Disease
Dermatitis Herpetiformis
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
PHASE2
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 ...
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 dis...
Eligibility Criteria
Inclusion
- 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
- Other gastrointestinal or hepatic disease besides celiac disease
- Selective IgA deficiency
- Use of dapsone or diaphenylsulfone
- Pregnancy and breast-feeding
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00962182
Start Date
August 1 2008
End Date
December 1 2017
Last Update
March 6 2018
Active Locations (2)
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1
Heim Pal Children's Hospital
Budapest, Hungary, 1089
2
University of Debrecen
Debrecen, Hungary, H-4032