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

October 26, 2016 updated by: Alberto Lanzini, MD PhD, Università degli Studi di Brescia

Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet in Achieving Complete Mucosal Healing Among Celiac Patients With Persisting Minimal Duodenal Lesions During Gluten Free Diet [GluCED]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite strict adherence to gluten free diet (GFD), the complete healing of the duodenal mucosa of celiac patients is rarely achieved. The cause of the persistence of the inflammation is not yet understood.

It is well known that there is a high degree of variability in individual response to gluten with some patients worsening of duodenal histology upon exposure to very small amount of gluten.

This observation suggest that contamination with gluten of commercially available processed food and/or small amount of gluten in processed foods labeled "gluten-free" (less than 20 ppm) may prevent complete mucosal healing.

This explanation is indirectly supported by a study of Hollon et al. (2013) showing that persistence of gastrointestinal symptoms in celiac patients on a GFD is abolished, in 85% of cases, by the adoption of a diet based exclusively on naturally gluten-free products, and on the elimination from the diet of commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED).

The main aim of this study was to assess whether the complete healing of duodenal mucosa in patients with persistent Mars I-II lesions after 1 year on GFD i) could be achieved, as a proof of the concept, by the adoption of a GCED OR ii) may depend upon time of exposure to GFD. To achieve this aim investigators studied 2 cohorts of patients with Marsh I-II lesion after 1 year on GFD: cohort A re-byopsied after 3 month GCED , and cohort B re-biopsied after a minimum of further 2 years on standard GFD.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Marsh I-II lesion at 12-18 months after starting GFD
  • Negative Celiac Disease serology
  • Strict adherence to gluten free diet without digression

Exclusion Criteria:

  • presence of Gastrointestinal Symtoms
  • presence of Helicobacter pylori infection

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A, GCED cohort
GCED, Gluten Contamination Elimination Diet
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).
No Intervention: B, time cohort
Cohort B consisted of patients on long term follow-up that accepted a repeated biopsies 60 or more months later the first control biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologic classification
Time Frame: three months in cohort A, at least sixty months in cohort B
Assessment of Marsh class (0-I-II-III) on duodenal biopsies in participants from both cohorts
three months in cohort A, at least sixty months in cohort B

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Celiac disease serology
Time Frame: three months in cohort A, at least sixty months in cohort B
IgA t-TG (class A Antibodies anti tissue Transglutaminases) were measured in particiapnts serum at the same time of dudenal biopsy [Eu t-Tg Eurospital, Trieste, Italy]
three months in cohort A, at least sixty months in cohort B
TCR+ T cells count
Time Frame: three months in cohort A, sixty months in cohort B
TCR+ T cells were identified using a commercially available method suitable for formalin fixed paraffin embedded dudenal biopsies. A mean of the count of TCR+T cells was obtained with a cut-off value of 4 out of 100 epithelial cells.
three months in cohort A, sixty months in cohort B
Eosinophils count
Time Frame: three months in cohort A, sixty months in cohort B
Eosinophils were identified and counted on duodenal biopsies with a cut off value of 2 out of 100 epithelial cells.
three months in cohort A, sixty months in cohort B

Collaborators and Investigators

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

Sponsor

Università degli Studi di Brescia

Investigators

  • Study Director: barbara zanini, MD, PhD, Università degli Studi di Brescia

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

March 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD_GE_2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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