Immune Responses to Gluten

January 11, 2024 updated by: Jocelyn Silvester, Boston Children's Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 101 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celiac Disease
Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
Dietary supplement: Gluten Powder
Single oral dose of gluten powder
Experimental: Healthy Controls
Individuals without a diagnosis of celiac disease
Dietary supplement: Gluten Powder
Single oral dose of gluten powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Children's Hospital Colorado
Celiac Disease Foundation

Investigators

  • Principal Investigator: Jocelyn A Silvester, MD, PhD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00039708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant demographic and cytokine data collected during the trial, after deidentification.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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