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N/A

Gluten Challenge for Celiac Disease

N/A
Recruiting
Led By Bana Jabri, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gluten de-challenge group: Age 18 to 70 years old, Showing typical celiac disease symptoms, Not on a gluten-free diet
Control group: Age 18 to 70 years old, Females who are not pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline -12 months
Awards & highlights

Study Summary

This trial will study how celiac disease is caused and affects people, so better treatments can be developed for those with it.

Who is the study for?
Adults aged 18-70 with celiac disease can join this trial. Participants must have been diagnosed by biopsy at least a year ago and followed a strict gluten-free diet for the past year. Pregnant women, those with chronic GI diseases, uncontrolled blood disorders, or severe reactions to gluten are excluded.Check my eligibility
What is being tested?
The study is testing how eating a gluten-containing snack bar affects people with celiac disease. It looks at tissue damage and healing by examining interactions between gut cells, microbes, immune responses, genetics, and gluten.See study design
What are the potential side effects?
Eating the gluten snack may cause typical celiac symptoms like stomach pain, bloating, diarrhea or constipation in participants since they have been following a strict gluten-free diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-70, have celiac symptoms, and am not on a gluten-free diet.
Select...
I am between 18 and 70 years old and not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline -12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline -12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios
Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Gluten challenge groupExperimental Treatment1 Intervention
Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months
Group II: Gluten de-challenge groupActive Control1 Intervention
Suspected celiac disease either showing typical symptoms or positive celiac disease serology
Group III: Control groupActive Control1 Intervention
No history or symptoms of celiac disease

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER
3,216 Previous Clinical Trials
3,767,268 Total Patients Enrolled
8 Trials studying Celiac Disease
327 Patients Enrolled for Celiac Disease
California Institute of TechnologyOTHER
13 Previous Clinical Trials
2,949 Total Patients Enrolled
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,557 Total Patients Enrolled
1 Trials studying Celiac Disease
3,500 Patients Enrolled for Celiac Disease

Media Library

Gluten containing snack bar (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05680012 — N/A
Celiac Disease Research Study Groups: Gluten challenge group, Gluten de-challenge group, Control group
Celiac Disease Clinical Trial 2023: Gluten containing snack bar Highlights & Side Effects. Trial Name: NCT05680012 — N/A
Gluten containing snack bar (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680012 — N/A

Frequently Asked Questions

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

Is the age restriction for this clinical trial inclusive of those aged 55 and up?

"This medical study is seeking volunteers aged 18 or more and under 70 years of age."

Answered by AI

Are new participants being accepted in this clinical research endeavor?

"According to the clinicaltrials.gov entry, this trial has concluded its recruitment process as of December 23rd 2022 and is no longer looking for candidates. However, there are still 32 other medical studies that individuals can join at this time."

Answered by AI

What criteria must applicants meet to be accepted into this clinical research program?

"This trial seeks to enrol 220 persons afflicted with celiac disease, ranging in age from 18 to 70. To be eligible for the study, individuals must not currently follow a gluten-free diet, must not be female and pregnant, should have been diagnosed by intestinal biopsy at least 12 months prior, should adhere strictly to a gluten-free regimen over that same period of time and demonstrate typical symptoms of Celiac Disease."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Chicago
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Tissue Destruction and Healing in Celiac Disease
2023. "Tissue Destruction and Healing in Celiac Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05680012.
All > Celiac Disease Anaheim > Microbiome
~147 spots leftby Jun 2027
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