Study of Enzyme Supplements to Treat Celiac Disease

Phase 1

Completed

• Conditions: Celiac Disease; Dermatitis Herpetiformis
• Interventions: Drug: STAN1+gluten; Drug: STAN1; Drug: Placebo enzyme

• Registration Number: NCT00962182
• Lead Sponsor: Heim Pal Children's Hospital

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2014-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-04
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enzyme + gluten	STAN1+gluten	Enzyme and 500 mg gluten b.i.d. for 12 weeks
Enzyme treatment	STAN1	Enzyme for 12 weeks
Placebo control	Placebo enzyme	Placebo enzyme for 12 weeks

Primary Outcome Measures

Name	Time	Method
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in symptoms or rash (if any)	12 weeks
Favorable changes in morphometry in small bowel biopsy specimens	28 weeks
Negative seroconversion or drop of at least two dilution steps in the EMA test	12 weeks
Negative conversion for celiac antibodies in the blood by the rapid test	12 weeks

Trial Locations

Locations (2)

Heim Pal Children's Hospital; 🇭🇺 Budapest, Hungary

University of Debrecen; 🇭🇺 Debrecen, Hungary