Condition: Body Composition Changes · Malnutrition · Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
This description comes directly from the study's public registry record.
Antonio Giordano, MD, MSc, PhD · 0034 932919000 · dr.antoniogiordano@gmail.com
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| Unidad de Enfermedad Inflamatoria Intestinal | Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07162701