Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00962182
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2009-08-18
Brief Title:
Study of Enzyme Supplements to Treat Celiac Disease
Sponsor:
Heim Pal Childrens Hospital
Organization:
Heim Pal Childrens Hospital
Study Overview
Official Title:
Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None