NCT07619547From ClinicalTrials.govRecruiting

Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrolment target: 100
Started: 4 October 2026
Main results due: 1 June 2036
Study sites: 1
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 85 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

* 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

What this study is about

In the sponsor’s own words, from the registry.

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. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.

Objective:

To better understand IBD over time.

Eligibility:

Adults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.

Design:

Affected participants will have clinic visits every 6 months for 3 years.

Once a year, they will have these procedures:

A physical exam with blood and stool samples.

Ultrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.

Magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.

Colonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.

Upper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.

Questionnaires. Participants will answer questions about their disease and their diet.

Midyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires

Healthy relatives will have 1 blood draw for genetic tests.

Study sites(1)

National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07619547. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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