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RECRUITING
NCT07162701

Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

View on ClinicalTrials.gov

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.

Official title: Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

OBSERVATIONAL

Enrollment

48

Start Date

2025-07-15

Completion Date

2028-07-15

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Bioimpedance analysis

Patients' body composition will be assessed using bioimpedance analysis (Akern)

Locations (1)

Unidad de Enfermedad Inflamatoria Intestinal

Barcelona, Spain