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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:
ClinicalTrials.gov Identifier:
NCT00962182
First Posted: August 19, 2009
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanford University
Information provided by (Responsible Party):
Ilma R Korponay-Szabo, Heim Pal Children's Hospital
  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:


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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 18, 2009
First Posted: August 19, 2009
Last Update Posted: August 19, 2015
Last Verified: August 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