Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]
NCT ID: NCT02711696
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-03-31
2016-01-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A, GCED cohort
GCED, Gluten Contamination Elimination Diet
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).
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Negative Celiac Disease serology
* Strict adherence to gluten free diet without digression
Exclusion Criteria
* presence of Helicobacter pylori infection
18 Years
65 Years
ALL
No
Sponsors
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Università degli Studi di Brescia
OTHER
Responsible Party
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Alberto Lanzini, MD PhD
Associate Professor of Gastroenterology, PhD
Principal Investigators
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barbara zanini, MD, PhD
Role: STUDY_DIRECTOR
Università degli Studi di Brescia
Other Identifiers
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CD_GE_2013
Identifier Type: -
Identifier Source: org_study_id