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Celiac disease secrets revealed: how gluten wreaks havoc on the gut

NCT ID NCT05680012

Knowledge-focused Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This study aims to learn more about how celiac disease damages the gut and how it heals. Researchers will look at gut cells, bacteria, the immune system, and genetics in 220 adults. The goal is to better understand symptoms and improve care for people with celiac disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Gluten challenge group: 1. Age 18 to 75 years old 2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy 3. Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group: 1. Age 18 to 75 years old 2. Showing typical celiac disease symptoms 3. Not on a gluten-free diet Control group: 1. Age 18 to 75 years old 2. Females who are not pregnant Exclusion Criteria: Gluten challenge group: 1. Diagnosis of any severe complication of celiac disease 2. Diagnosis of other chronic, active GI disease 3. Selective IgA deficiency 4. Severe reaction to gluten exposure 5. Any clinically significant diseases 6. History of significant substance or alcohol abuse 7. Pregnant or lactating 8. Diagnosis of blood clotting disorders Gluten de-challenge group: 1. History of chronic inflammatory gastrointestinal disease 2. Gastrointestinal illness within the 4-week period prior to screening 3. History of lymphoproliferative disease 4. Uncontrolled blood clotting disorders 5. Any clinically significant diseases 6. History of significant substance or alcohol abuse Control group: 1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs 2. Known intestinal inflammation 3. Prior gastrointestinal surgery 4. Taking of antiplatelet agents or anticoagulants 5. Family history of celiac disease

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • California Institute of Technology

    NOT_YET_RECRUITING

    Pasadena, California, 91125, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • The University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.