Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]

Università degli Studi di Brescia

Status: Completed

Conditions: Celiac Disease

Treatments: Behavioral: GCED, Gluten Contamination Elimination Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02711696

CD_GE_2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

A, GCED cohort

Active Comparator group

Description:

GCED, Gluten Contamination Elimination Diet

Treatment:

Behavioral: GCED, Gluten Contamination Elimination Diet

B, time cohort

No Intervention group

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.