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Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]

NCT02711696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-10-27

No results posted yet for this study

Summary

The study assessed whether compete healing of duodenal mucosa in celiac patients with persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):

* could be achieved by adoption of a diet based exclusively on naturally gluten free products, with the elimination of commercially available processed food (GCED, Gluten Contamination Elimination Diet);
* may depend upon time of exposure to GFD.

Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:

* cohort A: patients re-biopsied after three months on GCED;
* cohort B: patients re-biopsied after a minimum of further two years on standard GFD.

Conditions

Interventions

BEHAVIORAL

GCED, Gluten Contamination Elimination Diet

A Gluten Free diet based exclusively on naturally gluten-free products and foods, with the elimination from the diet of all commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED).

Sponsors & Collaborators

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • barbara zanini, MD, PhD · Università degli Studi di Brescia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-06-30
Completion
2016-01-31

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Entities

Diseases

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 NCT02711696 on ClinicalTrials.gov