Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
Key facts
- Where
- Málaga, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 14 years old?
Source: NCT07362654, who can take part
Where in Spain
- Hospital Regional Universitario de MalagaMálaga, SpainContact: Rafael Martín Masot, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Trial code
- NCT07362654
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease
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.
Inclusion: 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: Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months; 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; Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity; Obesity defined as BMI ≥ 95th percentile according to WHO criteria.