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Study of Enzyme Supplements to Treat Celiac Disease

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ClinicalTrials.gov Identifier: NCT00962182
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Ilma R Korponay-Szabo, Heim Pal Children's Hospital

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 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


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




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 ]


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older 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

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

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    Key Record Dates
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:
Dermatitis
Celiac Disease
Dermatitis Herpetiformis
Skin Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases