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

Primary Purpose

Celiac Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GCED, Gluten Contamination Elimination Diet
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease,, Gluten Free Diet, Gluten contamination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    A, GCED cohort

    B, time cohort

    Arm Description

    GCED, Gluten Contamination Elimination Diet

    Cohort B consisted of patients on long term follow-up that accepted a repeated biopsies 60 or more months later the first control biopsy.

    Outcomes

    Primary Outcome Measures

    Histologic classification
    Assessment of Marsh class (0-I-II-III) on duodenal biopsies in participants from both cohorts

    Secondary Outcome Measures

    Celiac disease serology
    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]
    TCR+ T cells count
    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.
    Eosinophils count
    Eosinophils were identified and counted on duodenal biopsies with a cut off value of 2 out of 100 epithelial cells.

    Full Information

    First Posted
    March 7, 2016
    Last Updated
    October 26, 2016
    Sponsor
    Università degli Studi di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02711696
    Brief Title
    Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]
    Acronym
    GluCED
    Official Title
    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]
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Brescia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Celiac Disease
    Keywords
    Celiac Disease,, Gluten Free Diet, Gluten contamination

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A, GCED cohort
    Arm Type
    Active Comparator
    Arm Description
    GCED, Gluten Contamination Elimination Diet
    Arm Title
    B, time cohort
    Arm Type
    No Intervention
    Arm Description
    Cohort B consisted of patients on long term follow-up that accepted a repeated biopsies 60 or more months later the first control biopsy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    GCED, Gluten Contamination Elimination Diet
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Histologic classification
    Description
    Assessment of Marsh class (0-I-II-III) on duodenal biopsies in participants from both cohorts
    Time Frame
    three months in cohort A, at least sixty months in cohort B
    Secondary Outcome Measure Information:
    Title
    Celiac disease serology
    Description
    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]
    Time Frame
    three months in cohort A, at least sixty months in cohort B
    Title
    TCR+ T cells count
    Description
    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.
    Time Frame
    three months in cohort A, sixty months in cohort B
    Title
    Eosinophils count
    Description
    Eosinophils were identified and counted on duodenal biopsies with a cut off value of 2 out of 100 epithelial cells.
    Time Frame
    three months in cohort A, sixty months in cohort B

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    barbara zanini, MD, PhD
    Organizational Affiliation
    Università degli Studi di Brescia
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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