Immune Responses to Gluten

Boston Children's Hospital

Status: Enrolling

Conditions: Intestinal Disease; Gluten Sensitivity; Gastrointestinal Diseases; Celiac Disease; Celiac Disease in Children; Malabsorption Syndromes; Digestive System Disease

Treatments: Dietary Supplement: Gluten Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT05209568

P00039708

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 2 to 101 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Celiac Disease

Experimental group

Description:

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

Treatment:

Dietary Supplement: Gluten Powder

Healthy Controls

Experimental group

Description:

Individuals without a diagnosis of celiac disease

Treatment:

Dietary Supplement: Gluten Powder