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Recruiting

NCT Number: NCT05209568

Immune Responses to Gluten

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

Recruiting

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Key information

Conditions

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

Age range

2 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten Powder

Dietary Supplement

Single oral dose of gluten powder

Primary outcomes

  1. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn A Silvester, MD, PhD

CONTACT

[email protected]

617-355-8880

Marisa Stahl, MD, MSCS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Celiac Disease Foundation
  • Children's Hospital Colorado

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 26, 2022
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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