NCT05209568

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jan 2023Sep 2029

First Submitted

Initial submission to the registry

January 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

5.7 years

First QC Date

January 13, 2022

Last Update Submit

April 18, 2025

Conditions

Celiac DiseaseMalabsorption SyndromesDigestive System DiseaseIntestinal DiseaseGastrointestinal DiseasesGluten SensitivityCeliac Disease in Children

Keywords

glutencytokineT cell immune response

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 4 hours

Study Arms (2)

Celiac Disease

EXPERIMENTAL

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

Dietary Supplement: Gluten Powder

Healthy Controls

EXPERIMENTAL

Individuals without a diagnosis of celiac disease

Dietary Supplement: Gluten Powder

Interventions

Gluten PowderDIETARY_SUPPLEMENT

Single oral dose of gluten powder

Celiac DiseaseHealthy Controls

Eligibility Criteria

Age2 Years - 101 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31457091BACKGROUND

  • 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.

    PMID: 31505020BACKGROUND

  • 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.

    PMID: 31483515BACKGROUND

MeSH Terms

Conditions

Celiac DiseaseMalabsorption SyndromesDigestive System DiseasesIntestinal DiseasesGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jocelyn A Silvester, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyn A Silvester, MD, PhD

CONTACT

617-355-8880jocelyn.silvester@childrens.harvard.edu

Marisa Stahl, MD, MSCS

CONTACT

marisa.stahl@childrenscolorado.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Celiac Disease Program

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 26, 2022

Study Start

January 15, 2023

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal

Locations

US(2)