Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease

NCT07619547 | Not Yet Recruiting

• 2 other identifiers: 10002555002555-DK
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Immune System; Inflammation; gastroenterology

Outcome Measures

Primary Outcomes (1)

• To collect longitudinal clinical data and specimens, with the goal of identifying novel biomarkers correlating with disease activity or response to therapy

  3 years

Study Arms (2)

Affected participants

participants affected with inflammatory bowel disease

Unaffected family members

unaffected family member of participant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected inflammatory bowl disease

You may qualify if:

• 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 features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and/or
• a defined genetic syndrome/mutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD
• 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
• Adults 18 - 99 years of age
• In good general health
• No medical diagnosis of IBD

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Unable or unwilling to provide informed consent
• Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Inflammation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristi C Briggs, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristi C Briggs, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2036
• Last Updated: June 12, 2026

Record last verified: 2026-05-27

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)