NCT00962182

Study of Enzyme Supplements to Treat Celiac Disease

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Heim Pal Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Celiac Disease
• Dermatitis Herpetiformis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-12-01
• Completion: 2017-12-01
• First posted: 2009-08-19
• Last updated: 2018-03-06

Locations

2 sites across 1 country: Hungary