Study of Enzyme Supplements to Treat Celiac Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Heim Pal Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanford University
Information provided by:
Heim Pal Children's Hospital
ClinicalTrials.gov Identifier:
NCT00962182
First received: August 18, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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:


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: February 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pre-intervention placebo phase
Placebo enzyme for 4 weeks
Drug: Placebo enzyme
3-4 capsules/day at meals
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
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

Contacts
Contact: Ilma Korponay-Szabo, M.D., Ph.D. +36-1-459-9192 Ilma.Korponay-Szabo@uta.fi
Contact: Judit Tumpek, M.D. +36-1-459-9100 ext 1334 tumpek.judit@freemail.hu

Locations
Hungary
Heim Pal Children's Hospital Recruiting
Budapest, Hungary, 1089
Contact: Ilma Korponay-Szabo, PhD    +36-1-459-9192    Ilma.Korponay-Szabo@uta.fi   
Contact: Judit Tumpek    +36-1-459-9100 ext 1334    tumpek.judit@freemail.hu   
Principal Investigator: Ilma Korponay-Szabo, M.D., Ph.D.         
Sub-Investigator: Judit Tumpek, M.D.         
University of Debrecen Recruiting
Debrecen, Hungary, H-4032
Contact: Ilma Korponay-Szabo, M.D., Ph.D.    +36-52-255-603 ext 56168    Ilma.Korponay-Szabo@uta.fi   
Contact: Eva Nemes, M.D., Ph.D.    +36-52-255-603 ext 56168    enemes@dote.hu   
Principal Investigator: Ilma Korponay-Szabo, M.D., Ph.D         
Sub-Investigator: Judit Tumpek, M.D.         
Sub-Investigator: Eva Nemes, M.D., Ph.D.         
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

No publications provided

Responsible Party: Ilma Korponay-Szabo, associate 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 18, 2009
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
Autoimmune Diseases
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Skin Diseases
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on October 22, 2014