Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Study of Enzyme Supplements to Treat Celiac Disease

This study is ongoing, but not recruiting participants.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Negative seroconversion or drop of at least two dilution steps in the EMA test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Negative conversion for celiac antibodies in the blood by the rapid test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in symptoms or rash (if any) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Favorable changes in morphometry in small bowel biopsy specimens [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
Health Authority: Hungary: National Institute for Food and Nutrition Science

Keywords provided by 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 29, 2016