Clinical trial NCT00962182: Study of Enzyme Supplements to Treat Celiac Disease
Official title: Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Celiac Disease
Dermatitis Herpetiformis
Keywords: celiac disease
transglutaminase antibody
Lead sponsor: Heim Pal Children's Hospital
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2009-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
timeFrame: 12 weeks
Secondary outcomes:
measure: Negative seroconversion or drop of at least two dilution steps in the EMA test
timeFrame: 12 weeks
measure: Negative conversion for celiac antibodies in the blood by the rapid test
timeFrame: 12 weeks
measure: Change in symptoms or rash (if any)
timeFrame: 12 weeks
measure: Favorable changes in morphometry in small bowel biopsy specimens
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heim Pal Children's Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen
Study officials:
affiliation: Heim Pal Children's Hospital
name: Ilma Korponay-Szabo, M.D., Ph.D.
role: STUDY_DIRECTOR
References: