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Pancreatic Enzyme Supplementation for Celiac Disease

NCT02475369 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-05-12

Study results available
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Summary

The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to:

1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet.
2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.

Conditions

Interventions

DRUG

pancrelipase

Sponsors & Collaborators

Principal Investigators

  • Ciaran Kelly, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • United States

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 NCT02475369 on ClinicalTrials.gov