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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Celiac Disease, Gluten Sensitivity, Autoimmune Diseases

In brief

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.

Key facts

Study ID

NCT07362654

Run by

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

People needed

51

Starts

2025-07-07

Expected to finish

2026-11-01

Last updated by the study team

2026-04-27

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 8 to 14 years at study entry.
• Diagnosis of celiac disease according to ESPGHAN 2020 criteria.
• At least 18 months on a strict gluten-free diet (GFD).
• Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.
• Asymptomatic from a gastrointestinal perspective in the preceding weeks.
• Ability to swallow the gluten/placebo preparation.
• Written informed consent from parents/legal guardians and assent from the child.

You may not qualify if…

• Obesity defined as BMI ≥ 95th percentile according to WHO criteria.
• Diagnosed inflammatory bowel disease or diabetes mellitus.
• Acute infectious illness at the time of inclusion.
• Chronic hepatic, pulmonary, renal, or rheumatologic disease.
• History of severe acute reactions to accidental gluten ingestion.
• Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months.
• Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.

Where it is running

• Hospital Regional Universitario de Málaga — Málaga, Spain (enrolling)

Full record on ClinicalTrials.gov

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