Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

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.
    

Intervention name(s): GCED, Gluten Contamination Elimination Diet
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Celiac Disease,; Gluten Free Diet; Gluten contamination