Clinical Trial

Impact of IBD Activity on Frailty in Patients Over 60 Years

Study acronym: FRAGIL
Recruiting
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Record status
This record was last updated May 7, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-02-19; most recent amendment 2026-05-06.
Status change: Not Yet Recruiting → Recruiting 2025-08-18
Trial Details
NCT Number NCT06844318
Lead Sponsor Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Conditions IBD
Enrollment 153 participants
Start Date 2025-04-14
Primary Completion 2026-07 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-07