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Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

NCT07162701 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Body Composition Changes
  • Malnutrition

Interventions

DIAGNOSTIC_TEST

Bioimpedance analysis

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

Sponsors & Collaborators

  • Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)

    collaborator UNKNOWN

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

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-07-15
Completion
2028-07-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162701 on ClinicalTrials.gov