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Gluten Challenge for Celiac Disease

N/A
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a body mass index (BMI) ≥17 and ≤40 kg/m2 and a body weight >45 kg at the Screening Visit
Be HLA-DQ2 and/or HLA-DQ8 positive as defined in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post challenge
Awards & highlights

Study Summary

This trial is looking at the effect of gluten on the T cell receptor (TCR) repertoire and the transcriptome in people with and without celiac disease.

Who is the study for?
This trial is for adults with biopsy-proven, well-controlled Celiac Disease (CeD) who have been on a gluten-free diet for at least 6 months. Participants must be in good health, have a BMI between 17 and 40 kg/m2, weigh over 45 kg, and test positive for HLA-DQ2 or HLA-DQ8. People with recent participation in other trials, significant diseases or allergies, cancer history (except nonmelanoma skin cancer), immune system issues including HIV/Hepatitis B/C seropositivity or those prone to severe gluten-triggered symptoms are excluded.Check my eligibility
What is being tested?
The study tests how T cell receptors (TCRs) in the gut and blood change after eating gluten powder. It looks at the genetic sequence of these TCRs before and after the challenge to understand celiac disease better. The trial also examines changes in small intestine histology post-gluten intake.See study design
What are the potential side effects?
Since this trial involves consuming gluten powder by people with CeD, expected side effects may include gastrointestinal discomfort such as bloating, abdominal pain, diarrhea or constipation; rash; headache; fatigue; and potentially more severe reactions depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 17 and 40, and I weigh more than 45 kg.
Select...
I am HLA-DQ2 or HLA-DQ8 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in peripheral blood TCR repertoire
Change from Baseline in small intestine TCR repertoire
Changes from baseline in small intestine and peripheral blood transcriptome
Secondary outcome measures
Change from Baseline in Small Intestine Histology Based on Intraepithelial Lymphocytes (IEL) Count per 100 epithelial cells
Change from Baseline in Small Intestine Histology Based on Villous Height (Microns), Crypt Depth (Microns) and Villous Height to Crypt Depth Ratio (Vh:Cd)
Identification and ex vivo functional validation of gluten-specific T cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gluten ChallengeExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
622 Previous Clinical Trials
380,711 Total Patients Enrolled
Clinical Trial AdministratorStudy DirectorRegeneron Pharmaceuticals

Media Library

Gluten Challenge Clinical Trial Eligibility Overview. Trial Name: NCT04614571 — N/A
Celiac Disease Research Study Groups: Gluten Challenge
Celiac Disease Clinical Trial 2023: Gluten Challenge Highlights & Side Effects. Trial Name: NCT04614571 — N/A
Gluten Challenge 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614571 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants in this clinical research endeavor?

"Affirmative. The clinical trial information hosted on clinicialtrials.gov confirms that this medical experiment, which was posted on November 2nd 2020, is actively recruiting volunteers for participation. Approximately 20 patients need to be enrolled from 1 select site."

Answered by AI

To which demographic is enrollment in this investigation open?

"This clinical trial is admitting 20 individuals - between 18 to 75 years old with celiac disease. In addition, applicants must also have a BMI of 17-40 kg/m2 and weigh more than 45 kilograms at their screening visit."

Answered by AI

What is the participation capacity of this clinical research project?

"Affirmative. Clinicaltrials.gov furnishes evidence that the investigation is actively recruiting, having been published on November 2nd 2020 and most recently updated on July 1st 2022. The researchers are looking for 20 individuals to enrol at a single site."

Answered by AI

Is geriatric patient enrollment accepted in this trial?

"According to the inclusion criteria for this medical trial, it is open to patients aged 18-75. For those who do not qualify due to age restrictions, there are a total of 12 studies available for individuals under 18 and 23 trials for people over 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Celiac Research Centre Mass General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge
2020. "T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614571.
All > Celiac Disease Boston > Celiac Disease
~2 spots leftby Sep 2024
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