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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00962182 |
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Date of registration:
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18/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Enzyme Supplements to Treat Celiac Disease
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Scientific title:
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Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00962182 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Hungary
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Contacts
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Name:
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Ilma Korponay-Szabo, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heim Pal Children's Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Celiac Disease
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Dermatitis Herpetiformis
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Intervention(s)
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Drug: Placebo enzyme
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Drug: STAN1
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Drug: STAN1+gluten
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Primary Outcome(s)
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Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Favorable changes in morphometry in small bowel biopsy specimens
[Time Frame: 28 weeks]
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Change in symptoms or rash (if any)
[Time Frame: 12 weeks]
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Negative conversion for celiac antibodies in the blood by the rapid test
[Time Frame: 12 weeks]
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Negative seroconversion or drop of at least two dilution steps in the EMA test
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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