Study of Enzyme Supplements to Treat Celiac Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2015 by Ilma R Korponay-Szabo, Heim Pal Children's Hospital.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborator:

Stanford University

Information provided by (Responsible Party):

Ilma R Korponay-Szabo, Heim Pal Children's Hospital

ClinicalTrials.gov Identifier:

NCT00962182

First received: August 18, 2009

Last updated: August 17, 2015

Last verified: August 2015

History of Changes

Purpose

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	Intervention	Phase
Celiac Disease Dermatitis Herpetiformis	Drug: STAN1 Drug: Placebo enzyme Drug: STAN1+gluten	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Celiac Disease Dietary Supplements

Genetic and Rare Diseases Information Center resources: Dermatitis Herpetiformis

U.S. FDA Resources

Further study details as provided by Ilma R Korponay-Szabo, Heim Pal Children's Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2015
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962182

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


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
Study First Received:	August 18, 2009
Last Updated:	August 17, 2015

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

ClinicalTrials.gov processed this record on September 21, 2017

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