Trial | NCT00962182  Report issue

Title

Study of Enzyme Supplements to Treat Celiac Disease
Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    latiglutenase ...

  • Study Participants

    38
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.
Study Started
Aug 31
2008
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2017
Last Update
Mar 06
2018

Drug STAN1

3-4 capsules/day at meals

Drug Placebo enzyme

3-4 capsules/day at meals

Drug STAN1+gluten

3-4 capsules/day at meals plus 500 mg gluten b.i.d

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

Criteria 

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
No Results Posted