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

Gastroenterology 2026 Open access

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Authors: A.James M. Daveson, Emma Craig, Alina Vitak, Robert S. Ware, Jennifer Schafer, Anuj Sehgal, Utpal Bose, Michelle J. Colgrave, Melinda Y. Hardy, Jason A. Tye-Din, Robert P. Anderson
DOI: 10.1053/j.gastro.2026.03.011
Cited by: 2
References: 25

Abstract

BACKGROUND & AIMS: Celiac disease is an immune-mediated enteropathy triggered by gluten ingestion. The effect of very small gluten exposures remains uncertain, contributing to international variations in food-labeling standards. Interleukin 2 (IL2) rises rapidly after gluten ingestion, serving as a biomarker of immune activation. We aimed to identify the lowest gluten dose that elicits a measurable IL2 response and accompanying symptoms in treated celiac disease. METHODS: , ie, the dose at which p% of people respond) was estimated by interval-censored survival analysis. RESULTS: was 0.1 mg (95% CI, 0.0-0.3 mg). Symptom scores increased after challenges but not beyond placebo. CONCLUSIONS: Acute IL2 release occurs at gluten doses below current food-labeling thresholds. Symptoms are unreliable at exposures

Fields of Study & Subjects

Celiac Disease Research and Management Microscopic Colitis Gastrointestinal motility and disorders

Publication details

Journal / source
Gastroenterology
Publisher
Elsevier BV
Volume
171
Issue
2
Pages
285–297
Publication date
26 March 2026
Language
EN