Immune Responses to Gluten

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boston Children's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jocelyn A Silvester, MD, PhD
Principal Investigator Affiliation Boston Children's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease, Malabsorption Syndromes, Digestive System Disease, Intestinal Disease, Gastrointestinal Diseases, Gluten Sensitivity, Celiac Disease in Children
Additional Details

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.

Arms & Interventions


Experimental: Celiac Disease

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

Experimental: Healthy Controls

Individuals without a diagnosis of celiac disease


Dietary Supplement: - Gluten Powder

Single oral dose of gluten powder

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora, Colorado




Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Marisa Stahl, MD, MSCS


Boston Children's Hospital, Boston, Massachusetts




Boston Children's Hospital

Boston, Massachusetts, 02115

Site Contact

Jocelyn A Silvester, MD, PhD


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