Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease (CELLiomicS)

NCT07362654 NA RECRUITING

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.

Details

Lead sponsor	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Phase	NA
Status	RECRUITING
Enrolment	51
Start date	2025-07-07
Completion	2026-11

Conditions

• Celiac Disease
• Gluten Sensitivity
• Autoimmune Diseases

Interventions

• Placebo
• Gluten 50 mg
• Gluten 5 g
• Collection of blood, stool and urine samples on Day 1 and Day 8.

Primary outcomes

• Change in peripheral blood immune cell gene expression after controlled gluten ingestion — Day 1 to Day 8
  Change from baseline (Day 1) to post-intervention (Day 8) in gene expression profiles of peripheral blood immune cells measured by single-cell RNA sequencing (scRNA-seq).
• Change in peripheral blood T-cell receptor repertoire after controlled gluten ingestion — Day 1 to Day 8
  Change from baseline (Day 1) to post-intervention (Day 8) in T-cell receptor (TCR) diversity and clonality in peripheral blood T cells measured by TCR sequencing

Countries

Spain