Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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 criteria

Qualifiers

Any sex.

Age between 18 and 64 years.

Patients with a definitive diagnosis (>3 months) of Crohn's disease or ulcerative colitis, according to European Crohn's and Colitis Organization criteria.

Moderate-to-severe disease luminal activity, with an indication for biologic or JAKi therapy for the induction of clinical remission.

Disqualifiers

Unclassified IBD.

History of intestinal resection for IBD, with the exception of ileocecal resection.

Short bowel syndrome.

Indication for medical treatment due to postsurgical recurrence.

Trial design

Treatments tested in this trial

  • Bioimpedance analysis

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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

Lead sponsor

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

Collaborator