NAZA Prospective Study on Inflammatory Bowel Disease Comparing Biologic Treatments in Crohns Disease and Ulcerative Colitis Including Non-IBD Controls Undergoing Colonoscopy

What this Trial Is About

This observational study aims to compare inflammatory markers between people with Inflammatory Bowel Diseases IBD, including Crohns disease and Ulcerative Colitis, and those without IBD. It focuses on patients with moderate to severely active disease who are switching to new targeted biologic therapies. The study also includes a control group of participants without IBD undergoing routine colonoscopy screening. Researchers hope to better understand IBD and improve treatment prediction and disease management. Participants with Crohns disease or Ulcerative Colitis will be receiving biologic therapies prescribed by their doctors as part of standard care, including anti-TNF therapy, vedolizumab, ustekinumab, or upadacitinib depending on their condition. They will provide blood and stool samples at three timepoints baseline, 3 months, and 12 months. Additional tissue biopsies will be collected during routine endoscopic procedures. Control participants will provide similar samples during routine colonoscopies. Throughout the study, participants will undergo routine clinical assessments and sample collections to analyze inflammatory pathways and molecular markers. The main outcome measured is the comparison of the IL-23Th17 inflammatory axis between IBD patients and healthy controls over time. Secondary analyses include detailed molecular and microbial characterizations. The study will continue until the end of 2027, with ongoing monitoring of all participants.

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study