Immune Responses to Gluten

Sponsor

Boston Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05209568

Collaborator

Children's Hospital Colorado (Other), Celiac Disease Foundation (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease Malabsorption Syndromes Digestive System Disease Intestinal Disease Gastrointestinal Diseases Gluten Sensitivity Celiac Disease in Children	Dietary Supplement: Gluten Powder	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celiac Disease Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology	Dietary Supplement: Gluten Powder Single oral dose of gluten powder
Experimental: Healthy Controls Individuals without a diagnosis of celiac disease	Dietary Supplement: Gluten Powder Single oral dose of gluten powder

Arm

Intervention/Treatment

Experimental: Celiac Disease

Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology

Dietary Supplement: Gluten Powder

Single oral dose of gluten powder

Experimental: Healthy Controls

Individuals without a diagnosis of celiac disease

Dietary Supplement: Gluten Powder

Single oral dose of gluten powder

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 101 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Wheat allergy
Type 1 diabetes
BMI z-score < -2
History of more than minimal symptoms following gluten exposure on a gluten-free diet
Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results