A Prospective, Double Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a "Gluten Friendly" Bread in Population With Celiac Disease

Background: Gluten ingestion leads to small intestinal mucosal injury in patients with celiac disease (CD), necessitating rigid, life-long exclusion of gluten from diet. Current therapies based on gluten-free dietary regimes, are also impairing social life, increased expenses for gluten free products, personal dissatisfaction and frustration. In addition, gluten-free products often have a low content of vitamins, such as vitamins B, ions such as calcium, iron, zinc and magnesium, as well of fibres. An alternative to the exclusion of gluten from diet may be the detoxification of gluten without affecting the technological performance of the flour and dough. Recently, we succeeded in developing a new and innovative method to detoxify gluten proteins from cereal grains: the modified stuff was capable to retain nutritional and technological properties of wheat proteins, and proved to be safe to celiac and gluten-sensitive patients. This innovation is usually referred to as "gluten friendly".

Objective: To establish the efficacy and safety of a prolonged exposure to the "Gluten Friendly trademark (™)" bread in patients with celiac disease.

Design: A prospective, double-blind, placebo-controlled, randomized trial to be conducted on adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for >2 years. Before enrollment, consenting patients will have to sign an informed consent form with full details of the aims of the study, and an explanation of the experimental procedures of the study. At the baseline evaluation (t 0 ), patients will undergo a clinical examination, an upper gastrointestinal endoscopy for the histologic evaluation of the duodenal mucosa, and a blood drawing for routine chemistry and anti-transglutaminase (ATGA) and anti-endomysium (EMA) antibodies checking. Eligible to be enrolled into the study will be patients with undetectable ATGA and EMA antibodies. They will be randomly assigned to one of three experimental regimens:

1. the control arm: patients will maintain a commercially available GFD and receive bread containing 3 gr of cornstarch daily for 12 weeks; these patients will serve as controls (Group A)
2. the innovative arm 1: patients will be have to continue the GFD supplemented with 3 gr of "gluten friendly"™ bread daily for 12 weeks (Group B)
3. the innovative arm 2: patients will be have to continue the GFD supplemented with 6 gr of "gluten friendly"™ bread daily for 12 weeks (group C).

All patients will be provided with a diary card to monitor their adherence to the assigned treatments and to register their acceptance of the experimental breads. Either patients and attending physicians will maintain blindness about the treatment assignment throughout t the study period.