Scientists watch immune system in action to unlock IBD mysteries

NCT ID NCT00001184

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 12 times

Summary

This study aims to learn how the immune system controls inflammation in the gut for people with Crohn's disease or ulcerative colitis. Up to 1,000 participants aged 0 to 75 will receive standard medical care and may provide blood, tissue, or white blood cell samples. No experimental treatments are involved; the goal is to gather information to develop better therapies in the future.

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.

Participants

About 1,000 people

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

Started

Aug 1998

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

Clinical

Ages

1 day 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: 1. Patients with a verifiable diagnosis of Crohn s disease, ulcerative colitis, or IBD known to be associated with a co-existing condition and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes OR 2. Patients with clinical features consistent with an unclassified inflammatory bowel disease and histologic evidence of inflammation of the intestine OR 3. Patients with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), including but not limited to abdominal pain, fistulae, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms (pyoderma, erythema nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified. OR 4. Patients who have a defined genetic syndrome linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD 5. All subjects to be enrolled will be between ages 0-75 (Participants coming to the NIH Clinical Center must meet age and weight requirements of the clinical center, but \> 18 must years old for patients without IBD and may be as young as 0-2 years old for mail-in samples). 6. To participate in the research biopsies during endoscopy, subjects must have the following lab values within two weeks of the procedure: * Hematocrit \> 30% * Platelet count \> 100,000 * PT INR \< 1.3 or PTT prolonged by \< 3 seconds 7. Ability to consent to the protocol on their own. INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS: 1. Must be willing to undergo blood draw and/or upper endoscopy and colonoscopy with biopsy to obtain material for research purposes. 2. Must be \>=18 years old. 3. Must be willing to submit samples for storage. INCLUSION OF EMPLOYEES IN THE NIH INTRAMURAL STUDIES: NIH employees and members of their immediate families may participate in this protocol. We will follow the Guidelines for the Inclusion of Employees in NIH Research Studies and will give each employee a copy of the NIH information sheet on Employee Research Participation. For NIH employees: 1. Neither participation nor refusal to participate will have an effect, either beneficial or adverse, on the participant s employment or work situation. 2. The NIH information sheet regarding NIH employee research participation will be distributed to all potential subjects who are NIH employees. 3. The employee subject s privacy and confidentiality will be preserved in accordance with NIH Clinical Center and NIAID policies, which define the scope and limitations of the protections. 4. For NIH employee subjects, consent will be obtained by an individual independent of the employee s team. Those in a supervisory position to any employee and co-workers of the employee will not obtain consent. The protocol study staff will be trained annually on obtaining potentially sensitive and private information from co-workers or subordinates. This training will be reinforced as needed, at weekly team meetings. EXCLUSION CRITERIA: 1. Failure to meet the inclusion criteria. 2. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS: 1. History of inflammatory bowel disease. 2. Acute systemic or intestinal infection requiring antibiotics 3. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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