Oat safety for celiac disease patients: theoretical analysis correlates adverse symptoms in clinical studies to contaminated study oats.

Inclusion of oats in a gluten-free (GF) diet can provide whole grain nutritional benefits to celiac disease (CD) patients, but there has been debate regarding oat safety for these individuals. This is because of conflicting research findings, with inconsistencies attributed to varying CD subject's sensitivities to "pure" oats. Clinical trials to date have assumed oats provided to subjects to be lightly contaminated, if at all. This assumption is challenged here since oat's propensity to be "kernel" contaminated with gluten sources like wheat and barley has recently been shown to significantly complicate confirmation of a GF state. We therefore hypothesize that clinical studies may have inadvertently provided pill-like gluten kernels intermittently to study subjects, leading to adverse outcomes that could potentially explain inconsistencies between study conclusions. To test this theory, potential gluten contamination of oats used in a cross-section of 12 important oat feeding studies has been estimated, done according to descriptions of oats used, published contamination rates for various oat types, and study oat dosages. Expected gluten exposures were found to be at levels to elicit clinical effects in a large portion of CD patients, correlating with observed clinical reaction rates in those studies (P value = .0006). Estimated gluten doses were found insufficient, however, to affect morphological outcomes, whereas only 1 study had 1 case. Our analysis provides a new perspective with which to view oat safety study conclusions and justifies new clinical trials using today's higher-purity GF oats to settle the oat safety for CD patient debate.