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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00962182
Other study ID # HP-03
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 18, 2009
Last updated March 4, 2018
Start date August 2008
Est. completion date December 2017

Study information

Verified date March 2018
Source Heim Pal Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 2017
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
STAN1
3-4 capsules/day at meals
Placebo enzyme
3-4 capsules/day at meals
STAN1+gluten
3-4 capsules/day at meals plus 500 mg gluten b.i.d

Locations

Country Name City State
Hungary Heim Pal Children's Hospital Budapest
Hungary University of Debrecen Debrecen

Sponsors (2)

Lead Sponsor Collaborator
Heim Pal Children's Hospital Stanford University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA 12 weeks
Secondary Negative seroconversion or drop of at least two dilution steps in the EMA test 12 weeks
Secondary Negative conversion for celiac antibodies in the blood by the rapid test 12 weeks
Secondary Change in symptoms or rash (if any) 12 weeks
Secondary Favorable changes in morphometry in small bowel biopsy specimens 28 weeks
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