Impact of IBD Activity on Frailty in Patients Over 60 Years

Launched by GRUPO ESPANOL DE TRABAJO EN ENFERMEDAD DE CROHN Y COLITIS ULCEROSA · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the activity of inflammatory bowel disease (IBD) affects frailty in older patients, specifically those aged 60 and above. Frailty is a condition that can make people weaker and more vulnerable to health issues. The researchers want to find out if treating IBD more actively can help improve frailty and reduce the risk of complications, such as hospitalizations or even death, in these patients. They will also look at different ways to measure frailty to see which one best predicts the risk of these complications.

To participate in the trial, individuals need to be at least 60 years old and have a diagnosis of IBD (like Crohn's disease or ulcerative colitis). They should also be starting a new treatment for their IBD based on specific health criteria. Participants will be asked to sign a consent form, and during the study, their frailty, IBD activity, and other health conditions will be monitored over time. This trial aims to gather important information that could help improve the care of older patients with IBD.

Gender

ALL

Eligibility criteria

• 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.