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
  • Gluten Sensitivity
  • Celiac Disease in Children

Recruitment Status

RECRUITING

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.

Eligibility Criteria

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

Phase

NA

Gender

ALL

Min Age

2 Years

Max Age

101 Years

Download Date

2025-04-23

Principal Investigator

Primary Investigator

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Contact Info
Jocelyn A Slivester, MD, PhD
jocelyn.silvester@childrens.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Intervention

Intervention Type

DIETARY_SUPPLEMENT

Intervention Name

Gluten Powder

Contact

For more information and to contact the study team:

Immune Responses to Gluten NCT05209568 Jocelyn A Slivester, MD, PhD jocelyn.silvester@childrens.harvard.edu