Study of Enzyme Supplements to Treat Celiac Disease

March 4, 2018 updated by: Ilma R Korponay-Szabo, Heim Pal Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1089
        • Heim Pal Children's Hospital
      • Debrecen, Hungary, H-4032
        • University of Debrecen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Negative seroconversion or drop of at least two dilution steps in the EMA test
Time Frame: 12 weeks
12 weeks
Negative conversion for celiac antibodies in the blood by the rapid test
Time Frame: 12 weeks
12 weeks
Change in symptoms or rash (if any)
Time Frame: 12 weeks
12 weeks
Favorable changes in morphometry in small bowel biopsy specimens
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heim Pal Children's Hospital

Collaborators

Stanford University

Investigators

  • Study Director: Ilma Korponay-Szabo, M.D., Ph.D., Heim Pal Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 4, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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