Immunogenetic HLA-DQ and IgG serological profiles in individuals with self-reported wheat/gluten sensitivity: a retrospective real-world evidence study

IntroductionMany patients report adverse symptoms following wheat/gluten consumption. As “Self-Reported Wheat/Gluten Sensitivity” lacks gold-standard biomarkers, characterizing biological profiles in Western populations is essential for precision management.

This study analyzes immunogenetic (HLA-DQ) and serological (IgG) patterns in a real-world clinical cohort.MethodsA retrospective observational study used Real-World Evidence (RWE) from 100 symptomatic individuals (2019–2024) selected via non-probabilistic convenience sampling. Participants underwent HLA-DQ genotyping and serum IgG reactivity testing for wheat/gluten via a validated ELISA-based assay.

Data normality was formally assessed using the Shapiro-Wilk test, revealing a non-parametric distribution (W=0.59, p<0.001). Consequently, inferential analyses included Chi-square (X2) tests for categorical associations, Spearman’s rank correlation (rs), and Odds Ratio (OR) calculations with 95% Confidence Intervals (95% CI).ResultsA 100% cumulative frequency of HLA-DQ susceptibility variants was observed.

The immunogenetic landscape revealed complex heterozygosity: DQ1 was most prevalent (56%), followed by DQ2 (54%), DQ3 (40%), and DQ8 (33%). DQ8 (X2 = 10.24; p=0.001) and DQ3 (X2 = 4.84; p=0.028) were significant markers.