Clinical Trial

Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

Study acronym: BAMBIE
Recruiting
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Record status
This record was last updated September 9, 2025 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07162701
Lead Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Conditions Body Composition Changes, Malnutrition
Enrollment 48 participants
Start Date 2025-07-15
Primary Completion 2026-07-15 (estimated)
Study Completion 2028-07-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-09