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Study of Enzyme Supplements to Treat Celiac Disease

NCT00962182 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

STAN1

3-4 capsules/day at meals

DRUG

Placebo enzyme

3-4 capsules/day at meals

DRUG

STAN1+gluten

3-4 capsules/day at meals plus 500 mg gluten b.i.d

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2014-12-31
Completion
2017-12-31

Countries

  • Hungary

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00962182 on ClinicalTrials.gov