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Gluten Challenge for Celiac Disease
N/A
Recruiting
Led By Jocelyn A Silvester, MD, PhD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 hours
Awards & highlights
Study Summary
This trial looks at how people with celiac disease and healthy controls react to gluten powder.
Who is the study for?
This trial is for people who have been on a gluten-free diet for at least 4 weeks. It's specifically for those with celiac disease confirmed by tests and healthy individuals willing to eat gluten powder for the study. People with wheat allergies, severe underweight issues (BMI z-score < -2), Type 1 diabetes, or other conditions that could affect the study can't participate.Check my eligibility
What is being tested?
The trial is testing how eating gluten powder affects immune responses in people with celiac disease compared to healthy controls. Participants will consume gluten after maintaining a strict gluten-free diet to see how their bodies react.See study design
What are the potential side effects?
Since this involves consuming gluten, participants especially those with celiac disease may experience digestive discomfort, such as bloating, gas, diarrhea or constipation; skin rashes; headaches; fatigue; and possibly pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
Trial Design
2Treatment groups
Experimental Treatment
Group I: Healthy ControlsExperimental Treatment1 Intervention
Individuals without a diagnosis of celiac disease
Group II: Celiac DiseaseExperimental Treatment1 Intervention
Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,330 Total Patients Enrolled
2 Trials studying Celiac Disease
240 Patients Enrolled for Celiac Disease
Children's Hospital ColoradoOTHER
115 Previous Clinical Trials
5,127,215 Total Patients Enrolled
1 Trials studying Celiac Disease
96 Patients Enrolled for Celiac Disease
Celiac Disease FoundationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to wheat.I experience significant symptoms when I eat gluten, despite being on a gluten-free diet.You are willing to eat gluten-containing foods as part of the study.My celiac disease diagnosis was confirmed through blood tests or tissue samples.I have Type 1 diabetes.Your body mass index (BMI) is very low for your age and height.You have been following a gluten-free diet for at least 4 weeks.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Celiac Disease
- Group 2: Healthy Controls
Celiac Disease Patient Testimony for trial: Trial Name: NCT05209568 — 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 any slots available for this experiment at the moment?
"The clinical trial in question, which was posted on October 1st 2022 and last updated 18th July of the same year, is not currently seeking participants. That being said, there are 220 other trials actively recruiting at this moment."
Answered by AI
Am I eligible to enroll in this research endeavor?
"Applicants who wish to participate in this clinical trial should have intestinal issues and be between 2-101 years old. Around 60 candidates will receive an invitation for consideration."
Answered by AI
Is this investigation enrolling participants aged 18 or older?
"Qualifying for this clinical trial requires an age between 2 and 101 years."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
South Carolina
Massachusetts
Other
How old are they?
18 - 65
What site did they apply to?
Children's Hospital Colorado
Boston Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m willing to try anything.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Will I need to travel to Colorado at my own expense?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Boston Children's Hospital: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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