How IBD activity affects frailty in people aged 60 and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, longitudinal observational cohort of patients with Crohn's disease or ulcerative colitis aged 60 years or older who start medical treatment for clinically or biologically active disease. At enrolment four clinical frailty indices and comorbidity scores will be calculated and detailed IBD characteristics and treatments recorded. Participants will be reassessed at 3, 6, and 12 months for frailty, comorbidities, IBD activity, treatment changes, adverse events, hospitalizations, and mortality. The study will compare which frailty index best predicts complications and whether improvement in IBD activity is associated with reversal or reduction of frailty and related risks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.
* Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to clinical activity based on PRO2 scales (UC: PRO \>4; CD: PRO2 \>14) and/or biological activity (fecal calprotectin ≥500 mg/kg, C-reactive protein ≥10 mg/L).
* Signed informed consent for inclusion.

Exclusion Criteria:

* Lack or withdrawal of informed consent.
* Unclassified/indeterminate colitis.
* Change in medical treatment solely due to adverse events.
* Initiation of treatment only with salicylates and/or topical steroids for disease activity.
* Treatment intensification to manage disease activity.
* Patients with an ostomy.
* Comorbidities with a life expectancy of less than one year.

Where it's running

• Hospital Universitario Araba
  Vitoria-Gasteiz, Alava, Spain Recruiting
• Hospital Germans Trias i Pujol
  Badalona, Barcelona, Spain Recruiting
• Hospital de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Althaia Manresa
  Manresa, Barcelona, Spain Recruiting
• Hospital del Mataró
  Mataró, Barcelona, Spain Recruiting
• Consorci Sanitari de Terrassa
  Terrassa, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Margalida Calafat, MD, PhD — Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
• Study coordinator: Erika Araya
• Email: secretariacientifica3@geteccu.org
• Phone: +34 674682070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.