Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07619547
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
Jun 1, 2036
Completion
Jun 1, 2036

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Affected participants
    participants affected with inflammatory bowel disease
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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