Immune Regulation in Ulcerative Colitis or Crohn s Disease
Observational · No treatment assigned · 1 site · National Institute of Allergy and Infectious Diseases (NIAID)
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease, Ulcerative Colitis and Chrohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 1 Day to 75
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- INCLUSION CRITERIA:
- 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…
- changes OR
- Patients with clinical features consistent with an unclassified inflammatory bowel disease and histologic evidence of inflammation of the intestine OR
- 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…
- nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified. OR
Plus 18 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1000 participants are expected to take part.
- The study has 1 group.
- Start date: 1998-08-07.
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- 1
Main thing being measured
- To identify the molecular abnormalities that result in inflammatory bowel diseases and develop novel therapies based on these discoveries. (at close of study)
In the researchers’ words
This study will investigate in patients with Crohn s disease and ulcerative colitis how the body s immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments. Patients between the ages of 0 and 75 years of age with Crohn s disease or…
Words you might see
- Colonoscopy: a camera exam of the large intestine (colon).
- Endoscopy: a camera exam inside the digestive tract.
- Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
- INR: a blood test of how quickly blood clots; it can reflect liver function.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease; Ulcerative Colitis; Chrohn's Disease |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 1000 (estimated) |
| Start date | 1998-08-07 |
| First posted | 1999-11-04 |
| Last updated | 2026-10-16 |
| Official title | A Natural History Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut |
| ClinicalTrials.gov ID | NCT00001184 |
Interventions
- None listed
Full eligibility criteria (from the record)
* 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.Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda, Maryland | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.