NCT07619547 Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
| NCT ID | NCT07619547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-11-05 |
| Primary Completion | 2036-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-11-05 with a primary completion date of 2036-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kristi C Briggs, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT07619547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07619547 currently recruiting?
Yes, NCT07619547 is actively recruiting participants. Contact the research team at kristi.briggs@nih.gov for enrollment information.
Where is the NCT07619547 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07619547 clinical trial?
NCT07619547 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is Kristi C Briggs, M.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 100 participants.