Children's immune response to small amounts of gluten

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.