Actively Recruiting

Phase Not Applicable
Age: 2Years - 101Years
All Genders
Healthy Volunteers
NCT05209568

Immune Responses to Gluten

Led by Boston Children's Hospital · Updated on 2025-04-23

400

Participants Needed

2

Research Sites

350 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

C

Children's Hospital Colorado

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Immune Responses to Gluten

Who Can Participate

Age: 2Years - 101Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • On a gluten-free diet for 64 4 weeks
  • Willing to consume gluten for research
  • For the celiac disease arm, diagnosis confirmed by serology and/or histology
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

J

Jocelyn A Silvester, MD, PhD

CONTACT

M

Marisa Stahl, MD, MSCS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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