Celiac DiseaseNCT05680012
Tissue Destruction and Healing in Celiac Disease
A study testing Gluten containing snack bar in people with Celiac Disease, run by University of Chicago at 3 sites in United States.
Trial summary
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Gluten containing snack bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jul 2023to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gluten challenge group:
- Age 18 to 75 years old
- Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
- Follow a strict gluten-free diet for at least the 12 consecutive months
- Gluten de-challenge group:
- Age 18 to 75 years old
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- Showing typical celiac disease symptoms
- Not on a gluten-free diet
- Control group:
- Age 18 to 75 years old
- Females who are not pregnant
Who cannot join
- Gluten challenge group:
- Diagnosis of any severe complication of celiac disease
- Diagnosis of other chronic, active GI disease
- Selective IgA deficiency
- Severe reaction to gluten exposure
- Any clinically significant diseases
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- History of significant substance or alcohol abuse
- Pregnant or lactating
- Diagnosis of blood clotting disorders
- Gluten de-challenge group:
- History of chronic inflammatory gastrointestinal disease
- Gastrointestinal illness within the 4-week period prior to screening
- History of lymphoproliferative disease
- Uncontrolled blood clotting disorders
- Any clinically significant diseases
- History of significant substance or alcohol abuse
- Control group:
- Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
- Known intestinal inflammation
- Prior gastrointestinal surgery
- Taking of antiplatelet agents or anticoagulants
- Family history of celiac disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Bana Jabri, MD, bjabri@bsd.uchicago.edu
Sonia Kupfer, MD, skupfer@bsd.uchicago.edu
- Not yet recruiting
California Institute of Technology
Pasadena, California, 91125
Rustem Ismagilov, PhD, 626-395-8130, rustem.admin@caltech.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Joseph Murray, MD, Murray.Joseph@mayo.edu
Chadrick Hinson, 507-266-0237, Hinson.chadrick@mayo.edu
About this study
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
Read the detailed description
Celiac disease is an autoimmune enteropathy characterized by chronic inflammation of the small intestinal mucosa triggered by gluten uptake that occurs in genetically susceptible individuals carrying the specific class II human leucocyte antigens (HLA) DQ2 and DQ8 alleles. There is a spectrum in intestinal tissue damage associated with celiac disease. Some individuals develop inflammatory immunity in the absence of tissue damage, while others experience tissue damage ranging from partial to total villous atrophy. Persistent mucosal damage is associated with several severe complications, including lymphoproliferative malignancy and bone diseases. In addition, individuals with active celiac disease display a wide range of clinical symptoms, including metabolic defects that are not correlated to the degree of villous atrophy. Although much progress has been made in understanding celiac disease, major gaps remain in understanding biological mechanisms underlying inter-individual differences in clinical presentations and capacity to heal while maintaining a gluten-free diet.
- Conditions
- Celiac Disease
- Being tested
- Gluten containing snack bar
- Keywords
- gluten-free diet, HLA-DQ2, HLA-DQ8, microbiome, metagenomics, intestinal epithelial cells
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten containing snack barDietary supplement
Ingest snack bars containing 3 grams of gluten every day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gluten challenge group | Experimental | Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months Receives: Dietary Supplement: Gluten containing snack bar |
| Gluten de-challenge group | No intervention | Suspected celiac disease either showing typical symptoms or positive celiac disease serology |
| Control group | No intervention | No history or symptoms of celiac disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios
villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Measured: baseline - 6 weeks
Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios
Villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Measured: baseline -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start14 Jul 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic, California Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Bana Jabri, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680012
- Sponsor's protocol ID
- IRB22-1138
- Other IDs
- RC2DK133947
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Destruction and Healing in Celiac Disease
- ClinicalTrials.gov ID
- NCT05680012
- Acronym / sponsor ID
- IRB22-1138
- Conditions
- Celiac Disease
- Keywords
- gluten-free diet, HLA-DQ2, HLA-DQ8, microbiome, metagenomics, intestinal epithelial cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic, California Institute of Technology
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
Detailed description
Celiac disease is an autoimmune enteropathy characterized by chronic inflammation of the small intestinal mucosa triggered by gluten uptake that occurs in genetically susceptible individuals carrying the specific class II human leucocyte antigens (HLA) DQ2 and DQ8 alleles. There is a spectrum in intestinal tissue damage associated with celiac disease. Some individuals develop inflammatory immunity in the absence of tissue damage, while others experience tissue damage ranging from partial to total villous atrophy. Persistent mucosal damage is associated with several severe complications, including lymphoproliferative malignancy and bone diseases. In addition, individuals with active celiac disease display a wide range of clinical symptoms, including metabolic defects that are not correlated to the degree of villous atrophy. Although much progress has been made in understanding celiac disease, major gaps remain in understanding biological mechanisms underlying inter-individual differences in clinical presentations and capacity to heal while maintaining a gluten-free diet.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluten challenge group | Experimental | Dietary Supplement: Gluten containing snack barDiagnosis of celiac disease by intestinal biopsy and serology for at least 12 months |
| Gluten de-challenge group | No intervention | –Suspected celiac disease either showing typical symptoms or positive celiac disease serology |
| Control group | No intervention | –No history or symptoms of celiac disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 75 years old
- Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
- Follow a strict gluten-free diet for at least the 12 consecutive months
- Age 18 to 75 years old
- Showing typical celiac disease symptoms
Key exclusion criteria (22 listed)
- Diagnosis of any severe complication of celiac disease
- Diagnosis of other chronic, active GI disease
- Selective IgA deficiency
- Severe reaction to gluten exposure
- Any clinically significant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten containing snack barIngest snack bars containing 3 grams of gluten every day for 6 weeks. | Dietary supplement | Gluten challenge group |
Primary outcome
Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios
Time frame: baseline - 6 weeks
villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios
Time frame: baseline -12 months
Villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bana Jabri, MD principal investigator
University of Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten containing snack bar in people with Celiac Disease, run by University of Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonia Kupfer, MD ((773) 834-1438, skupfer@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios (time frame: baseline - 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.