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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
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,362 Previous Clinical Trials
3,065,741 Total Patients Enrolled
9 Trials studying Celiac Disease
4,328 Patients Enrolled for Celiac Disease
California Institute of TechnologyOTHER
16 Previous Clinical Trials
4,129 Total Patients Enrolled
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
839,916 Total Patients Enrolled
1 Trials studying Celiac Disease
1,090 Patients Enrolled for Celiac Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,233 Total Patients Enrolled
3 Trials studying Celiac Disease
234 Patients Enrolled for Celiac Disease
Bana Jabri, MDPrincipal InvestigatorUniversity of Chicago

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
~140 spots leftby Jun 2027
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