Impact of IBD Activity on Frailty in Patients Over 60 Years
Recruiting now
Conditions studied: IBD
In brief
The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years. The main questions it aims to answer are: 1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease? 2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.
Key facts
- Study ID
- NCT06844318
- Run by
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- People needed
- 153
- Starts
- 2025-04-14
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-07
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Hospital Universitario Araba — Vitoria-Gasteiz, Alava, Spain (enrolling)
- Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain (enrolling)
- Hospital de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
- Althaia Manresa — Manresa, Barcelona, Spain (enrolling)
- Hospital del Mataró — Mataró, Barcelona, Spain (enrolling)
- Consorci Sanitari de Terrassa — Terrassa, Barcelona, Spain (enrolling)
- Hospital Mútua de Terrassa — Terrassa, Barcelona, Spain (enrolling)
- Hospital Viladecans — Viladecans, Barcelona, Spain (enrolling)
- Hospital Sierrallana de Torrelavega — Torrelavega, Cantabria, Spain (enrolling)
- Hospital de Toledo — Toledo, Castille-La Mancha, Spain (enrolling)
- Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain (enrolling)
- Hospital de Henares — San Sebastián de los Reyes, Madrid, Spain (enrolling)
- Hospital San Agustín de Avilés — Avilés, Principality of Asturias, Spain (enrolling)
- Hospital de Cabueñes — Gijón, Principality of Asturias, Spain (enrolling)
- Hospital Universitario Central de Astúrias — Oviedo, Principality of Asturias, Spain (enrolling)
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain (enrolling)
- Hospital Dr Balmis — Alicante, Valencia, Spain (enrolling)
- Hospital Denia — Denia, Valencia, Spain (enrolling)
- Hospital Royo Villanova — San Gregorio, Zaragoza, Spain (enrolling)
- Complejo Asistencial de Ávila — Ávila, Spain (enrolling)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
- Hospital Universitario de Burgos — Burgos, Spain (enrolling)
- Hospital Universitari Dr Josep Trueta — Girona, Spain (enrolling)
- Hospital Juan Ramón Jiménez — Huelva, Spain (enrolling)
- Hospital Universitario Lucus Augusti — Lugo, Spain (enrolling)
Full record on ClinicalTrials.gov
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