Recruiting

Observational Study

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Code:

NCT07619547

Conditions

Inflammatory Bowel Disease

Crohn's Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Inflammatory Bowel Disease

Crohn's Disease

Ulcerative Colitis

Study ID

NCT07619547

Start date

Sep 28, 2026

Status verified date

Sep 21, 2026

Completion date

Jun 1, 2036

Anticipated

Primary completion date

Jun 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Affected participants

participants affected with inflammatory bowel disease

Unaffected family members

unaffected family member of participant

Primary outcome measure

  • To collect longitudinal clinical data and specimens, with the goal of identifying novel biomarkers correlating with disease activity or response to therapy [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Kristi C Briggs, M.D.

(301) 480-2785kristi.briggs@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Last update posted

Sep 23, 2026

Last verified

Sep 21, 2026

Keywords

  • Immune System
  • Inflammation
  • gastroenterology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.