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

NCT02711696 | Completed

• 1 other identifier: CD_GE_2013
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Celiac Disease

Keywords

Celiac Disease,; Gluten Free Diet; Gluten contamination

Outcome Measures

Primary Outcomes (1)

• Histologic classification

  Assessment of Marsh class (0-I-II-III) on duodenal biopsies in participants from both cohorts

  three months in cohort A, at least sixty months in cohort B

Secondary Outcomes (3)

• Celiac disease serology

  three months in cohort A, at least sixty months in cohort B

• TCR+ T cells count

  three months in cohort A, sixty months in cohort B

• Eosinophils count

  three months in cohort A, sixty months in cohort B

Study Arms (2)

A, GCED cohort

ACTIVE COMPARATOR

GCED, Gluten Contamination Elimination Diet

Behavioral: GCED, Gluten Contamination Elimination Diet

B, time cohort

NO INTERVENTION

Cohort B consisted of patients on long term follow-up that accepted a repeated biopsies 60 or more months later the first control biopsy.

Interventions

GCED, Gluten Contamination Elimination Diet BEHAVIORAL

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).

A, GCED cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Marsh I-II lesion at 12-18 months after starting GFD
• Negative Celiac Disease serology
• Strict adherence to gluten free diet without digression

You may not qualify if:

• presence of Gastrointestinal Symtoms
• presence of Helicobacter pylori infection

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• barbara zanini, MD, PhD

  Università degli Studi di Brescia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology, PhD

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 17, 2016
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share