Study of Enzyme Supplements to Treat Celiac Disease
Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
1 other identifier
interventional
38
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2008
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 6, 2018
March 1, 2018
6.3 years
August 18, 2009
March 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
12 weeks
Secondary Outcomes (4)
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
Study Arms (3)
Enzyme treatment
EXPERIMENTALEnzyme for 12 weeks
Placebo control
PLACEBO COMPARATORPlacebo enzyme for 12 weeks
Enzyme + gluten
EXPERIMENTALEnzyme and 500 mg gluten b.i.d. for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other gastrointestinal or hepatic disease besides celiac disease
- Selective IgA deficiency
- Use of dapsone or diaphenylsulfone
- Pregnancy and breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heim Pal Children's Hospitallead
- Stanford Universitycollaborator
Study Sites (2)
Heim Pal Children's Hospital
Budapest, 1089, Hungary
University of Debrecen
Debrecen, H-4032, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ilma Korponay-Szabo, M.D., Ph.D.
Heim Pal Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
August 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2017
Last Updated
March 6, 2018
Record last verified: 2018-03