A Randomized Double-Blind, Placebo-Controlled Dose-Response Study to Assess the Gluten Threshold Dose in Celiac Disease - PubMed

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A randomized double-blind, placebo-controlled dose-response study was conducted to assess the gluten threshold dose in treated celiac disease patients.
The study involved 51 adults with biopsy-proven celiac disease on a gluten-free diet for over 2 years, who underwent three oral gluten or placebo challenges.
Serum interleukin-2 (IL-2) served as a biomarker, with a ≥2-fold rise within 6 hours as the primary outcome to measure immune activation.
Gluten induced dose-dependent IL-2 elevations, with responses observed at doses as low as 3 mg, but no response at 1 mg, 2 mg, 5 mg, or placebo.
Estimated eliciting doses were ED50 at 111 mg, ED10 at 2.4 mg, ED05 at 0.8 mg, and ED01 at 0.1 mg, based on interval-censored survival analysis.
Patient-reported symptom scores increased after challenges but did not differ significantly from placebo, indicating symptoms are unreliable at exposures below 1000 mg.
The findings suggest that acute IL-2 release occurs at gluten doses below current food-labelling thresholds, providing a framework for defining exposure limits based on immune activation.

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