Immune Responses to Gluten

Not Applicable

Recruiting

• Conditions: Celiac Disease in Children; Malabsorption Syndromes; Digestive System Disease; Gastrointestinal Diseases; Celiac Disease; Intestinal Disease; Gluten Sensitivity
• Interventions: Dietary Supplement: Gluten Powder

• Registration Number: NCT05209568
• Lead Sponsor: Boston Children's Hospital

Brief Summary

This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

Detailed Description

This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Study Start: 2023-01-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celiac Disease	Gluten Powder	Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
Healthy Controls	Gluten Powder	Individuals without a diagnosis of celiac disease

Primary Outcome Measures

Name	Time	Method
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten	Baseline, 4 hours	To determine the change in serum IL-2 level from baseline after a single oral dose of gluten

Trial Locations

Locations (2)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States