Children's immune response to small amounts of gluten
Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease
This study tests whether giving small, controlled amounts of gluten to children with celiac disease causes measurable changes in their immune cells.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga) |
| Trial ID | NCT07362654 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled parallel-group study enrolls children 8–14 years old with confirmed celiac disease who have maintained a strict gluten-free diet for at least 18 months. Participants are randomly assigned to receive placebo, 50 mg gluten, or 5 g gluten once daily for three days to mimic accidental low-level or larger dietary exposures. Blood, stool, and urine samples are collected before dosing and five days after the last dose, and immune cells are analyzed using single-cell RNA sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics. The goal is to define dose-dependent systemic immune and molecular signatures triggered by controlled gluten exposure in children.
Who should consider this trial
Good fit: Children aged 8–14 with biopsy- or serology-confirmed celiac disease who have followed a strict gluten-free diet for at least 18 months, are asymptomatic, can swallow the study preparation, and have negative fecal gluten immunogenic peptides are ideal candidates.
Not a fit: Children with a history of severe acute reactions to gluten, active infections, obesity, inflammatory bowel disease, diabetes, recent immunosuppressive therapy, those outside the 8–14 age range, or not on a strict gluten-free diet are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, this work could identify immune markers that help detect or monitor accidental gluten exposure and inform safer management for children with celiac disease.
How similar studies have performed: Prior gluten-challenge studies in adults and older children have demonstrated immune responses to gluten, but applying single-cell RNA and T-cell receptor sequencing to low-dose challenges in pediatric patients is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Málaga
- Hospital Regional Universitario de Málaga — Málaga, Spain (Recruiting)
Study contacts
- Principal investigator: Rafael Martín Masot, MD, PhD — Hospital Regional Universitario de Málaga / IBIMA-BIONAND
- Study coordinator: Rafael Martín Masot, MD, PhD
- Email: rafammgr@uma.es
- Phone: +34 951290000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.