Immune Responses to Gluten

Launched by BOSTON CHILDREN'S HOSPITAL · Jan 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system reacts to gluten in people with celiac disease and healthy individuals. Celiac disease is a condition where eating gluten, a protein found in wheat, barley, and rye, can cause serious health issues. The researchers are looking for participants who have been on a gluten-free diet for at least four weeks and are willing to eat gluten for the study. To qualify for the celiac disease group, participants need to have a confirmed diagnosis of the condition.

The trial is currently recruiting participants of all genders aged 2 to 99 years. However, there are some important criteria to keep in mind: individuals who are pregnant, have a wheat allergy, or have certain other health conditions may not be eligible. Participants can expect to consume gluten powder as part of the research, and the study aims to better understand how their bodies respond. This information could help improve treatment options for celiac disease and related conditions in the future.

Gender

ALL

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