Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)
This is a single-center, prospective observational study aiming to describe changes in body composition (specifically, percentage of lean mass and phase angle) in patients with active inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The study will recruit patients with a confirmed IBD diagnosis who are starting biologic therapy or Janus kinase inhibitors (JAKi) to induce clinical remission. Body composition will be assessed using bioelectrical impedance analysis (BIA) at baseline (time 0), 24 weeks, and 52 weeks after starting medication. Clinical disease activity, endoscopic findings, and laboratory data will also be collected at various time points if available. The study has a total duration of 36 months, including a 12-18 month patient inclusion period and a 12-month follow-up. Patients will provide informed consent, and all treatment decisions will follow standard clinical practice, as this is a non-interventional observational study.
• Any sex.
• Age between 18 and 64 years.
• Patients with a definitive diagnosis (\>3 months) of Crohn's disease or ulcerative colitis, according to European Crohn's and Colitis Organization criteria.
• Moderate-to-severe disease luminal activity, with an indication for biologic or JAKi therapy for the induction of clinical remission.