RecruitingNCT07162701

Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

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

Sponsor

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

Enrollment

48 participants

Start Date

Jul 15, 2025

Study Type

OBSERVATIONAL

Conditions

Malnutrition Body Composition Changes

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how body composition (muscle mass, fat levels, and overall physical makeup) changes in people with inflammatory bowel disease (IBD) — including Crohn's disease and ulcerative colitis — who are starting a new biologic treatment. The goal is to understand whether body changes predict how well the treatment will work. **You may be eligible if...** - You are 18 to 64 years old - You have been diagnosed with Crohn's disease or ulcerative colitis for at least 3 months - Your IBD is moderately to severely active - You are starting a biologic therapy or JAK inhibitor to help your disease go into remission **You may NOT be eligible if...** - Your IBD type is unclassified - You have had significant intestinal surgery (other than ileocecal resection) - You have short bowel syndrome - You have active perianal (around the anus) disease or intestinal narrowing - You have previously participated in a drug trial for IBD - You do vigorous exercise regularly (more than 6 METs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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