Actively Recruiting
Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2026-04-27
51
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
F
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Lead Sponsor
H
Hospital Regional de Malaga
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, shown by negative fecal gluten immunogenic peptides before inclusion.
- No gastrointestinal symptoms in the weeks before the study.
- Ability to swallow the gluten or placebo preparation.
- Written informed consent from parents or legal guardians and assent from the child.
You will not qualify if you...
- Obesity defined as BMI at or above the 95th percentile per WHO criteria.
- Diagnosed inflammatory bowel disease or diabetes mellitus.
- Acute infectious illness at the time of inclusion.
- Chronic liver, lung, kidney, or rheumatologic diseases.
- History of severe acute reactions to accidental gluten ingestion.
- Use of oral corticosteroids or immunosuppressive therapy within the last 3 months.
- Any condition that might prevent safe participation or affect study integrity, as judged by investigators.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Actively Recruiting
Research Team
R
Rafael Martín Masot, MD, PhD
CONTACT
L
Lara María Bossini Castillo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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