NCT00962182|CompletedPhase 1/2DMC
Study of Enzyme Supplements to Treat Celiac Disease
Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
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Sponsor study identifier
interventional
38
1 country
2
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 18, 2009
Actual (reported)August 19, 2009
Actual (reported)December 2014
Actual (reported)December 2017
Actual (reported)Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
12 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
Change in symptoms or rash (if any)
12 weeks
Favorable changes in morphometry in small bowel biopsy specimens
28 weeks
Enzyme for 12 weeks
Placebo enzyme for 12 weeks
Enzyme and 500 mg gluten b.i.d. for 12 weeks
3-4 capsules/day at meals
3-4 capsules/day at meals
Heim Pal Children's Hospital
Budapest, 1089, Hungary
University of Debrecen
Debrecen, H-4032, Hungary
Ilma Korponay-Szabo, M.D., Ph.D.
Heim Pal Children's Hospital
38 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
3-4 capsules/day at meals plus 500 mg gluten b.i.d
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2014
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
March 6, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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