Study of Enzyme Supplements to Treat Celiac Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Celiac Disease; Dermatitis Herpetiformis	Drug: STAN1; Drug: Placebo enzyme; Drug: STAN1+gluten	Phase 1; Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	38 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
Study Start Date :	August 2008
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Enzyme treatment; Enzyme for 12 weeks	Drug: STAN1; 3-4 capsules/day at meals
Placebo Comparator: Placebo control; Placebo enzyme for 12 weeks	Drug: Placebo enzyme; 3-4 capsules/day at meals
Experimental: Enzyme + gluten; Enzyme and 500 mg gluten b.i.d. for 12 weeks	Drug: STAN1+gluten; 3-4 capsules/day at meals plus 500 mg gluten b.i.d

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Negative seroconversion or drop of at least two dilution steps in the EMA test [ Time Frame: 12 weeks ]
2. Negative conversion for celiac antibodies in the blood by the rapid test [ Time Frame: 12 weeks ]
3. Change in symptoms or rash (if any) [ Time Frame: 12 weeks ]
4. Favorable changes in morphometry in small bowel biopsy specimens [ Time Frame: 28 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Hungary
Heim Pal Children's Hospital
Budapest, Hungary, 1089
University of Debrecen
Debrecen, Hungary, H-4032

Sponsors and Collaborators

Heim Pal Children's Hospital

Stanford University

Investigators

Study Director:	Ilma Korponay-Szabo, M.D., Ph.D.	Heim Pal Children's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ilma R Korponay-Szabo, Professor, Heim Pal Children's Hospital
ClinicalTrials.gov Identifier:	NCT00962182 History of Changes
Other Study ID Numbers:	HP-03
First Posted:	August 19, 2009
Last Update Posted:	March 6, 2018
Last Verified:	March 2018

Keywords provided by Ilma R Korponay-Szabo, Heim Pal Children's Hospital:

celiac disease; transglutaminase antibody

Additional relevant MeSH terms:

Celiac Disease; Dermatitis; Dermatitis Herpetiformis; Skin Diseases; Malabsorption Syndromes; Intestinal Diseases	Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Skin Diseases, Vesiculobullous; Autoimmune Diseases; Immune System Diseases