Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, observational, natural history study designed to generate hypotheses about immune-system changes in inflammatory bowel disease. Participants will attend semiannual visits for up to three years, with yearly blood, stool, abdominal ultrasound, and MRI assessments to collect clinical data and biospecimens. The study also includes participation by adult family members for immune and genetic analyses to understand heritable factors. Primary goals are to identify biomarkers linked to disease activity or therapy response, and to study immune, genetic, and nutritional aspects of chronic GI inflammation. Interventions are not assigned; the study is exploratory and hypothesis-generating.

Why it matters

Who can join: the full rules

* 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

Where it's running

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

Study contacts

• Principal investigator: Kristi C Briggs, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Kristi C Briggs, M.D.
• Email: kristi.briggs@nih.gov
• Phone: (301) 480-2785

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Continued TAK-279 treatment in adults with ulcerative colitis or Crohn's disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.