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

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study ID
NCT07362654
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DIETARY_SUPPLEMENT
    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.
  • Gluten 50 mg — DIETARY_SUPPLEMENT
    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.
  • Gluten 5 g — DIETARY_SUPPLEMENT
    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.
  • Collection of blood, stool and urine samples on Day 1 and Day 8. — PROCEDURE
    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)

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo Group
    Participants receive a placebo preparation once daily on Days 1, 2, and 3. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation.
  • Experimental: Low-Dose Gluten (50 mg)
    Participants receive 50 mg of gluten once daily on Days 1, 2, and 3, simulating accidental low-level exposure. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation.
  • Experimental: High-Dose Gluten (5 g)
    Participants receive 5 g of gluten once daily on Days 1, 2, and 3, simulating a dietary transgression. Blood samples are collected on Day 1 (baseline) and Day 8 (post-intervention). Participants and evaluators remain blinded to allocation.

Primary Outcome Measure

Change in peripheral blood immune cell gene expression after controlled gluten ingestion [ Time Frame: Day 1 to Day 8 ]

Central Contacts

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