Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease (NCT07362654) | Clinical Trial Compass
RecruitingNot Applicable
Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
Spain51 participantsStarted 2025-07-07
Plain-language 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.
Who can participate
Age range
8 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in peripheral blood immune cell gene expression after controlled gluten ingestion
Timeframe: Day 1 to Day 8
2
Change in peripheral blood T-cell receptor repertoire after controlled gluten ingestion
Timeframe: Day 1 to Day 8
Trial details
NCT IDNCT07362654
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud