This trial is active, not recruiting.

Conditions celiac disease, dermatitis herpetiformis
Treatments stan1, placebo enzyme, stan1+gluten
Phase phase 1/phase 2
Sponsor Heim Pal Children's Hospital
Collaborator Stanford University
Start date August 2008
End date December 2014
Trial size 40 participants
Trial identifier NCT00962182, HP-03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Enzyme for 12 weeks
3-4 capsules/day at meals
(Placebo Comparator)
Placebo enzyme for 12 weeks
placebo enzyme
3-4 capsules/day at meals
Enzyme and 500 mg gluten b.i.d. for 12 weeks
3-4 capsules/day at meals plus 500 mg gluten b.i.d

Primary Outcomes

Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
time frame: 12 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 12 years up to 65 years old.

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

Additional Information

Official title Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Heim Pal Children's Hospital.