Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease.
Gautam Goel, Jason A Tye-Din, Shuo-Wang Qiao...
https://pubmed.ncbi.nlm.nih.gov/31457091Actively Recruiting
Phase Not Applicable
Age: 2Years - 101Years
All Genders
Healthy Volunteers
ID05209568
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten in People With and Without Celiac Disease
Led by Boston Children's Hospital · Updated on 2025-04-23
400
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
C
Children's Hospital Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying immune responses to gluten in people with celiac disease and healthy individuals. This open-label study focuses on measuring changes in serum interleukin-2 (IL-2) levels after participants consume a single oral dose of gluten powder. The study aims to understand how the immune system reacts to gluten in both affected and unaffected groups. Participants will be given a single dose of gluten powder to eat. The study includes two groups: individuals with a confirmed diagnosis of celiac disease based on serology or histology, and healthy controls without celiac disease. Blood samples will be collected before and 4 hours after gluten intake to measure cytokine levels, specifically IL-2. During the study, participants will provide blood samples to assess immune changes. Researchers will monitor the change in IL-2 levels from baseline to 4 hours post-gluten ingestion. The study is non-randomized and open-label, with no masking or placebo. The total participation includes the single gluten challenge and blood draws, with no long-term follow-up specified.
CONDITIONS
Brief Title
Immune Responses to Gluten
Who Can Participate
Age: 2Years - 101Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- On a gluten-free diet for 64 4 weeks
- Willing to consume gluten for research
- For the celiac disease group, diagnosis confirmed by serology and/or histology
You will not qualify if you...
- Pregnancy
- Wheat allergy
- Type 1 diabetes
- BMI z-score < -2
- History of more than minimal symptoms following gluten exposure while on a gluten-free diet
- Any other condition that might interfere with study participation or affect results, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Single Gluten Dose and Sampling
Duration - Single day
Participants consume a single oral dose of gluten powder and provide blood samples before and 4 hours after ingestion for cytokine measurement.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
J
Jocelyn A Silvester, MD, PhD
M
Marisa Stahl, MD, MSCS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Serum cytokines elevated during gluten-mediated cytokine release in coeliac disease.
G Goel, A J M Daveson, C E Hooi...
https://pubmed.ncbi.nlm.nih.gov/31505020Elevated serum interleukin-2 after gluten correlates with symptoms and is a potential diagnostic biomarker for coeliac disease.
Jason A Tye-Din, A James M Daveson, Hooi C Ee...
https://pubmed.ncbi.nlm.nih.gov/31483515