Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease, Crohn's Disease and Ulcerative Colitis. 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 18 to 85
- Any sex
Some of the main requirements, copied from the record:
- INCLUSION CRITERIA
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Affected Participant cohort:
- Adults 18 - 85 years of age
- History of:
- a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical…
Plus 6 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-10-21 (planned).
- Main results expected around 2036-06-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Affected participants
- Unaffected family members
Main thing being measured
- To collect longitudinal clinical data and specimens, with the goal of identifying novel biomarkers correlating with disease activity or response to therapy (3 years)
In the researchers’ words
Background: Inflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD.
Words you might see
- Colonoscopy: a camera exam of the large intestine (colon).
- Endoscopy: a camera exam inside the digestive tract.
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; Crohn's Disease; Ulcerative Colitis |
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 100 (estimated) |
| Start date | 2026-10-21 |
| Primary completion (est.) | 2036-06-01 |
| First posted | 2026-06-02 |
| Last updated | 2026-10-16 |
| Official title | Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07619547 |
Interventions
- None listed
Full eligibility criteria (from the record)
* INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: Affected Participant cohort: 1. Adults 18 - 85 years of age 2. History of: 1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and/or 2. a defined genetic syndrome/mutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD 3. Presence of a referring community physician who would be able to manage care outside of NIH Unaffected family member of participant: immediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD 1. Adults 18 - 99 years of age 2. In good general health 3. No medical diagnosis of IBD EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Unable or unwilling to provide informed consent 2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures
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.