Study of Enzyme Supplements to Treat Celiac Disease

Celiac Disease Clinical Trial

Official title:

Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962182
• Other study ID #: HP-03
• 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
• 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

Related Conditions & MeSH terms

• Celiac Disease
• Dermatitis
• Dermatitis Herpetiformis

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