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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 March 2018
Main ID:  NCT00962182
Date of registration: 18/08/2009
Prospective Registration: No
Primary sponsor: Heim Pal Children's Hospital
Public title: Study of Enzyme Supplements to Treat Celiac Disease
Scientific title: Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
Date of first enrolment: August 2008
Target sample size: 38
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 1/Phase 2
Countries of recruitment
Name:     Ilma Korponay-Szabo, M.D., Ph.D.
Affiliation:  Heim Pal Children's Hospital
Key inclusion & exclusion 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

Age minimum: 12 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Celiac Disease
Dermatitis Herpetiformis
Drug: Placebo enzyme
Drug: STAN1
Drug: STAN1+gluten
Primary Outcome(s)
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA [Time Frame: 12 weeks]
Secondary Outcome(s)
Change in symptoms or rash (if any) [Time Frame: 12 weeks]
Favorable changes in morphometry in small bowel biopsy specimens [Time Frame: 28 weeks]
Negative conversion for celiac antibodies in the blood by the rapid test [Time Frame: 12 weeks]
Negative seroconversion or drop of at least two dilution steps in the EMA test [Time Frame: 12 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Stanford University
Results available:
Date Posted:
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