RECRUITING

Immune Responses to Gluten

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Conditions

Celiac DiseaseMalabsorption SyndromesDigestive System DiseaseIntestinal DiseaseGastrointestinal DiseasesGluten SensitivityCeliac Disease in ChildrenglutencytokineT cell immune response

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-01-15
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05209568

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.

Ages Eligible for Study:2 Years to 101 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. On a gluten-free diet for ≥ 4 weeks
  2. 2. Willing to consume gluten for research
  3. 3. For the celiac disease arm, diagnosis confirmed by serology and/or histology
  1. 1. Pregnancy
  2. 2. Wheat allergy
  3. 3. Type 1 diabetes
  4. 4. BMI z-score \< -2
  5. 5. History of more than minimal symptoms following gluten exposure on a gluten-free diet
  6. 6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

Contacts and Locations

Study Contact

Jocelyn A Silvester, MD, PhD
CONTACT
617-355-8880
jocelyn.silvester@childrens.harvard.edu
Marisa Stahl, MD, MSCS
CONTACT
marisa.stahl@childrenscolorado.org

Principal Investigator

Jocelyn A Silvester, MD, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Jocelyn A Silvester, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

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 Registration Dates

Study Start Date2023-01-15
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2023-01-15
Study Completion Date2029-09-30

Terms related to this study

Keywords Provided by Researchers

  • gluten
  • cytokine
  • T cell immune response

Additional Relevant MeSH Terms

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