Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease

This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses. Using single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.

NCT Number	NCT07362654
Lead Sponsor	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Collaborators: Hospital Regional de Malaga, Andaluz Health Service, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Universidad de Málaga, Consorcio Centro de Investigación Biomédica en Red (CIBER), Biohealth Research Institute in Granada (ibs.GRANADA)
Conditions	Celiac Disease, Gluten Sensitivity, Autoimmune Diseases
Enrollment	51 participants
Start Date	2025-07-07
Primary Completion	2026-04 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-04-27