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

RecruitingNAAges 8 Years - 14 YearsAllFundación Pública Andaluza para la Investigación …
NCT07362654 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
Hospital Regional Universitario de Málaga
Málaga, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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