Immune Responses to Gluten

N/ARecruitingNCT05209568

Boston Children's Hospital400 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

400

Conditions

Celiac Disease Malabsorption Syndromes Digestive System Disease Intestinal Disease Gastrointestinal Diseases Gluten Sensitivity Celiac Disease in Children

Interventions

Gluten PowderDIETARY_SUPPLEMENT

Single oral dose of gluten powder

Eligibility

Sex: ALLMin age: 2 YearsMax age: 101 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Children's Hospital Colorado

Aurora, Colorado, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten

To determine the change in serum IL-2 level from baseline after a single oral dose of gluten

Time frame: Baseline, 4 hours

Central Contacts

Jocelyn A Silvester, MD, PhD

CONTACT

617-355-8880 jocelyn.silvester@childrens.harvard.edu

Marisa Stahl, MD, MSCS

CONTACT

marisa.stahl@childrenscolorado.org

Data from ClinicalTrials.gov

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