Immune Regulation in Ulcerative Colitis or Crohn s Disease
This NIH natural-history study is collecting clinical, immune, and genetic samples from people with Crohn’s disease and ulcerative colitis to better understand immune pathways and molecular causes of IBD. Those findings could help researchers develop new biomarkers and guide future therapies.
Patients with Crohn's disease or ulcerative colitis (including children and adults), parents/caregivers of pediatric patients, clinicians who refer patients for research, and researchers studying IBD immune mechanisms or genetics.
What To Know
This is a recruiting NIH observational study (natural history protocol) that aims to study how immune cells — especially lymphocytes — control inflammation in the gut in people with Crohn’s disease or ulcerative colitis.
The protocol does not test experimental drugs; participants continue to receive standard medical care and may have blood draws, leukapheresis, stool tests, imaging, and endoscopic biopsies as part of the research procedures.
If your care involves endoscopy or blood-based monitoring, samples and clinical data could be collected for detailed molecular, immunologic, and genetic analyses intended to identify disease mechanisms and biomarkers. Participation can include children and adults (ages 0–75) and may involve larger blood collections or leukapheresis for immune-cell studies.
Practical notes: clinical care decisions remain with your treating team; surgical consultation is only recommended if medically necessary. Participation requires meeting standard safety lab values for biopsy procedures and willingness to provide samples for storage.
This is an observational (non-interventional) protocol run by the NIH/NIAID. It collects blood, leukapheresis products, stool, imaging, and endoscopic biopsies as allowed by routine care.
Because it is a natural-history study, it seeks to generate data and samples rather than test a specific treatment; results would inform future research rather than provide direct therapeutic benefit.
