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
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease,, Gluten Free Diet, Gluten contamination
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
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
NCT ID
NCT02711696
First Posted
March 7, 2016
Last Updated
October 26, 2016
Sponsor
Università degli Studi di Brescia
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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