Clinical trial NCT02711696: Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [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
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac Disease,
Gluten Free Diet
Gluten contamination
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Histologic classification
timeFrame: three months in cohort A, at least sixty months in cohort B
Secondary outcomes:
measure: Celiac disease serology
timeFrame: three months in cohort A, at least sixty months in cohort B
measure: TCR+ T cells count
timeFrame: three months in cohort A, sixty months in cohort B
measure: Eosinophils count
timeFrame: three months in cohort A, sixty months in cohort B
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi di Brescia
name: barbara zanini, MD, PhD
role: STUDY_DIRECTOR
References: