Gluten selection method

In addition to the pivotal studies, several publications (Table 6.2) used other methods to test the response of individuals with celiac disease who were introduced to oats. These studies did not fulfill the selection criteria of pivotal studies namely an in vivo oats challenge with an intestinal/skin biopsy to assess the biological response to the introduction of oats into an otherwise gluten-free diet. Instead, they used various in vitro techniques to assess the immune response to avenin, or serology without an intestinal mucosal biopsy. Most of the methods used duodenal mucosal cultures prepared from biopsies or intestinal T cell lines obtained from individuals with celiac disease. Other studies measured the immunogenic reaction in peripheral lymphocytes or measured the presence of various antibodies in individuals with verified celiac disease who included oats in their diet, in comparison with a reference group (Table 6.2). Some of these studies used patients that were previously included in pivotal studies. These studies are identified with an asterisk ( ) in Table 6.2. 

Gluten was obtained from ProVim, a gluten-enriched flour, by a conventional dough-and-wash procedure (16). Gliadin was separated from the gluten by the method of Jones et al. (17). The surfactants selected for study were Myrj 45 [polyoxyethylene (8) stearate], Tween 60 [polyoxyethylene (20) sorbitan monostearate], Brij 35 [polyoxyethylene (23) lauryl ether], Brij 76 [polyoxyethylene (10) stearyl ether], Brij 78 [polyoxyethylene (20) stearyl ether], and calcium stearoyl-2-lactylate. (Note that the numbers in parentheses indicate the number of monomer units of ethylene oxide.) Working solutions were made up in 70% ethanol at 2.5 mg per 100 ml solution. 

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