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Immune Responses to Gluten

Primary Purpose

Celiac Disease, Malabsorption Syndromes, Digestive System Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gluten Powder

About this trial

This is an interventional other trial for Celiac Disease focused on measuring gluten, cytokine, T cell immune response

Eligibility Criteria

2 Years - 101 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

On a gluten-free diet for ≥ 4 weeks
Willing to consume gluten for research
For the celiac disease arm, diagnosis confirmed by serology and/or histology

Exclusion Criteria:

Pregnancy
Wheat allergy
Type 1 diabetes
BMI z-score < -2
History of more than minimal symptoms following gluten exposure on a gluten-free diet
Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

Sites / Locations

Children's Hospital ColoradoRecruiting
Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Celiac Disease

Healthy Controls

Arm Description

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

Individuals without a diagnosis of celiac disease

Outcomes

Primary Outcome Measures

Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten

To determine the change in serum IL-2 level from baseline after a single oral dose of gluten

Secondary Outcome Measures

Full Information

NCT ID

NCT05209568

First Posted

January 13, 2022

Last Updated

February 6, 2023

Sponsor

Boston Children's Hospital

Collaborators

Children's Hospital Colorado, Celiac Disease Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05209568

Brief Title

Immune Responses to Gluten

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2023 (Actual)

Primary Completion Date

September 30, 2028 (Anticipated)

Study Completion Date

September 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

Collaborators

Children's Hospital Colorado, Celiac Disease Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

gluten, cytokine, T cell immune response

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Celiac Disease

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy Controls

Arm Type

Experimental

Arm Description

Individuals without a diagnosis of celiac disease

Intervention Type

Dietary Supplement

Intervention Name(s)

Gluten Powder

Intervention Description

Single oral dose of gluten powder

Primary Outcome Measure Information:

Title

Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten

Description

To determine the change in serum IL-2 level from baseline after a single oral dose of gluten

Time Frame

Baseline, 4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

101 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: On a gluten-free diet for ≥ 4 weeks Willing to consume gluten for research For the celiac disease arm, diagnosis confirmed by serology and/or histology Exclusion Criteria: Pregnancy Wheat allergy Type 1 diabetes BMI z-score < -2 History of more than minimal symptoms following gluten exposure on a gluten-free diet Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jocelyn A Silvester, MD, PhD

Phone

617-355-8880

jocelyn.silvester@childrens.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Marisa Stahl, MD, MSCS

marisa.stahl@childrenscolorado.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jocelyn A Silvester, MD, PhD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marisa Stahl, MD, MSCS

Phone

720-777-2484

marisa.stahl@childrenscolorado.org

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jocelyn A Silvester, MD, PhD

Phone

617-355-8880

jocelyn.silvester@childrens.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

31457091

Citation

Goel G, Tye-Din JA, Qiao SW, Russell AK, Mayassi T, Ciszewski C, Sarna VK, Wang S, Goldstein KE, Dzuris JL, Williams LJ, Xavier RJ, Lundin KEA, Jabri B, Sollid LM, Anderson RP. Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease. Sci Adv. 2019 Aug 7;5(8):eaaw7756. doi: 10.1126/sciadv.aaw7756. eCollection 2019 Aug.

Results Reference

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PubMed Identifier

31505020

Citation

Goel G, Daveson AJM, Hooi CE, Tye-Din JA, Wang S, Szymczak E, Williams LJ, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Serum cytokines elevated during gluten-mediated cytokine release in coeliac disease. Clin Exp Immunol. 2020 Jan;199(1):68-78. doi: 10.1111/cei.13369. Epub 2019 Oct 1.

Results Reference

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PubMed Identifier

31483515

Citation

Tye-Din JA, Daveson AJM, Ee HC, Goel G, MacDougall J, Acaster S, Goldstein KE, Dzuris JL, Neff KM, Truitt KE, Anderson RP. Elevated serum interleukin-2 after gluten correlates with symptoms and is a potential diagnostic biomarker for coeliac disease. Aliment Pharmacol Ther. 2019 Oct;50(8):901-910. doi: 10.1111/apt.15477. Epub 2019 Sep 4.

Results Reference

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Immune Responses to Gluten

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