Immune Responses to Gluten

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2-101

SponsorBoston Children's Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

On a gluten-free diet for ≥ 4 weeks

Willing to consume gluten for research

For the celiac disease arm, diagnosis confirmed by serology and/or histology

Disqualifiers

Pregnancy

Wheat allergy

Type 1 diabetes

BMI z-score < -2

Trial design

Design model

Parallel

Treatments tested in this trial

Gluten Powder
Dietary supplement
Single oral dose of gluten powder

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Celiac DiseaseExperimental treatment 1 intervention

Group B: Healthy ControlsExperimental treatment 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Children's Hospital Colorado

Collaborator

Celiac Disease Foundation

Collaborator

Source ClinicalTrials.gov

Apply now