RecruitingNot ApplicableNCT07362654

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

Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease

Sponsor

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

Enrollment

45 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Celiac Disease Autoimmune Diseases Gluten Sensitivity

Summary

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.

Eligibility

Min Age: 8 YearsMax Age: 14 Years

Inclusion Criteria7

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 Criteria7

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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Interventions

DIETARY_SUPPLEMENTPlacebo

Placebo preparation identical in appearance and administration schedule to gluten doses. Administered once daily on Days 1, 2, and 3. Used as the comparator. Participants and evaluators remain blinded to allocation.

DIETARY_SUPPLEMENTGluten 50 mg

Participants receive 50 mg of gluten once daily on Days 1, 2, and 3. This dose simulates accidental low-level gluten exposure in children with celiac disease. Participants and evaluators remain blinded to allocation.

DIETARY_SUPPLEMENTGluten 5 g

Participants receive 5 g of gluten once daily on Days 1, 2, and 3. This dose simulates a dietary transgression in children with celiac disease. Participants and evaluators remain blinded to allocation.

PROCEDURECollection of blood, stool and urine samples on Day 1 and Day 8.

In addition to blood samples, stool and urine samples will be collected for complementary analyses (including fecal gluten immunogenic peptides (GIP) and exploratory metabolomic assays)