Compliance with the GFD was assessed every 15 days by careful examination

of a patient’s food diary (control level 1) followed, whenever possible, by a specific medical interview (control level 2). At the same time-points, a blood sample was obtained to detect EMA as a further index of adherence to the GFD (control level 3). All patients in this group presented excellent compliance with the GFD and completed the clinical phase of the study. Conversely, the NFR characterization was performed exclusively on 11 of 20 patients in this group who, after a reasonable period on a GFD, agreed to undergo a second duodenal biopsy. By preliminary evaluation, the subgroup click here of 11 patients appeared to be gender- and age-reflective of the overall group. Group 2.  Group 2 comprised treated CD patients (31 male/56 female, mean age 31·3, range 19–54 years) on a GFD from at least 12 months, and showing serum EMA-negative results. During the study, all patients continued to take a GFD and were followed regularly for 12 months. Compliance with the GFD was assessed every 15 days as described for group 1. Group 3.  Group 3 comprised healthy subjects (five male/10 female, mean age 28·7, range 18–55 years) not affected by CD or other autoimmune disease, and with no consanguinity

with CD patients. At study entry their sera were collected and stored at −70°C until tested. Two of the subjects in this group showed an NFR-like pattern in the absence of serum EMA. For ethical reasons, the

latter two subjects were not submitted to duodenal biopsy to exclude a subclinical form of CD. However, they agreed to undergo a GFD and to be monitored for 12 months. Adherence to Navitoclax ic50 the GFD was assessed every month as described for group 1. Both treated subjects presented excellent compliance to the GFD and completed the study. CD patients were selected from among the out-patients admitted to our gastrointestinal unit from January 2006 to December 2007 who showed clinical features described for groups 1 or 2, and who agreed to undergo the study protocol. The diagnosis of CD was made Bay 11-7085 in accordance with the procedure adopted worldwide [34], based on clinical case identification, serological screening and duodenal biopsy histology. Healthy subjects were selected among the blood donors admitted to our hospital from January 2006 to December 2007 who showed clinical features described for group 3, and who agreed to undergo the study protocol. The diagnosis of CD was excluded in individuals not clinically suspicious, with serum EMA-negative results. Because the suitability of oat as part of a GFD is still controversial [2], all the GFDs administered in this study included the withdrawal of any oat-based product. All procedures followed in this study were in accordance with the ethical standards of the institutional committee responsible for human experimentation. Furthermore, informed consent was obtained from each study participant.