An observational study in Body Composition Changes and Malnutrition, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 48 is below the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with IBD (Crohn's disease and ulcerative colitis)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pacients with ulcerative colitis
Diagnostic Test: Bioimpedance analysis
Patients with Crohn's disease
Diagnostic Test: Bioimpedance analysis
Patients' body composition will be assessed using bioimpedance analysis (Akern)
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 weeks
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 months
Plan to share: No — Due to local privacy regulations, data can only be shared upon written, motivated request and approval by the local IEC.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2026, 12 months after the start.
Of 174 non-industry observational studies under Malnutrition, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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