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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with IBD (Crohn's disease and ulcerative colitis)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bioimpedance analysis
Diagnostic testPatients' body composition will be assessed using bioimpedance analysis (Akern)
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Ulcerative colitis1 intervention
Group B: Crohn's disease1 intervention
Trial outcomes
Primary outcomes
1
Phase angle change
To describe the changes in Phase angle observed between week 0 (baseline) and week 24 after the commencement of biologic or JAK inhibitor therapy.
Time frame
24 weeks2
Body Composition change
To describe the changes in Lean Mass index observed between week 0 (baseline) and week 24 after the commencement of biologic or JAK inhibitor therapy.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov