Celiac Disease Clinical Trial
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]
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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