Examining immune responses to gluten in celiac disease and healthy individuals
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
This study tests how the immune system reacts to gluten in people with celiac disease compared to healthy individuals after eating a small amount of gluten.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 2 Years to 101 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05209568 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune responses triggered by gluten consumption in individuals diagnosed with celiac disease compared to healthy controls. It is a multi-site, open-label study where participants will consume a single dose of gluten powder and provide blood samples to measure cytokine levels before and four hours after ingestion. The goal is to better understand the immune mechanisms involved in celiac disease and how they differ from those in healthy individuals.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed diagnosis of celiac disease who have been on a gluten-free diet for at least four weeks.
Not a fit: Patients with wheat allergy, type 1 diabetes, or those who have a history of severe symptoms following gluten exposure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of celiac disease and lead to improved management strategies for patients.
How similar studies have performed: Other studies have explored immune responses to gluten, but this specific approach of a single-dose gluten challenge in a controlled setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. On a gluten-free diet for ≥ 4 weeks 2. Willing to consume gluten for research 3. For the celiac disease arm, diagnosis confirmed by serology and/or histology Exclusion Criteria: 1. Pregnancy 2. Wheat allergy 3. Type 1 diabetes 4. BMI z-score \< -2 5. History of more than minimal symptoms following gluten exposure on a gluten-free diet 6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Where this trial is running
Aurora, Colorado and 1 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jocelyn A Silvester, MD, PhD — Boston Children's Hospital
- Study coordinator: Jocelyn A Silvester, MD, PhD
- Email: jocelyn.silvester@childrens.harvard.edu
- Phone: 617-355-8880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.