BridgeMD
New treatment option for Celiac Disease
Official title Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease
ClinicalTrials.gov ID: NCT07362654
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 14
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Málaga, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Málaga, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.