Clinical Trial: Study of Enzyme Supplements to Treat Celiac Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity

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.

Detailed Summary: 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.
Sponsor: Heim Pal Children's Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Heim Pal Children's Hospital

Dates:
Date Received: August 18, 2009
Date Started: August 2008
Date Completion: December 2015
Last Updated: August 17, 2015
Last Verified: August 2015