Recruiting

Immune Responses

Sponsor:

Boston Children's Hospital

Code:

NCT05209568

Conditions

Celiac Disease

Malabsorption Syndromes

Digestive System Disease

Intestinal Disease

Gastrointestinal Diseases

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Interventions

Gluten Powder

Study Details

Brief summary:

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

Conditions

Celiac Disease

Malabsorption Syndromes

Digestive System Disease

Intestinal Disease

Gastrointestinal Diseases

Study ID

NCT05209568

Start date

Jan 15, 2023

Status verified date

Apr, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

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

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Celiac Disease

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

experimental: Healthy Controls

Individuals without a diagnosis of celiac disease

Interventions

Gluten Powder

Single oral dose of gluten powder

Primary outcome measure

  • Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten [ Time Frame: Baseline, 4 hours ]

Central Contacts and Locations

Central contacts

Jocelyn A Silvester, MD, PhD

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

Marisa Stahl, MD, MSCS

marisa.stahl@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Marisa Stahl, MD, MSCS

720-777-2484marisa.stahl@childrenscolorado.org

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jocelyn A Silvester, MD, PhD

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

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 23, 2025

Last verified

Apr, 2025

Keywords

  • gluten
  • cytokine
  • T cell immune response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-04-23.