NCT06844318 Impact of IBD Activity on Frailty in Patients Over 60 Years
| NCT ID | NCT06844318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| Condition | IBD |
| Study Type | OBSERVATIONAL |
| Enrollment | 153 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 153 participants in total. It began in 2025-04-14 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Margalida Calafat, MD, PhD
PRINCIPAL INVESTIGATOR
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Frequently Asked Questions
Who can join the NCT06844318 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying IBD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06844318 currently recruiting?
Yes, NCT06844318 is actively recruiting participants. Contact the research team at secretariacientifica3@geteccu.org for enrollment information.
Where is the NCT06844318 trial being conducted?
This trial is being conducted at Vitoria-Gasteiz, Spain, Badalona, Spain, L'Hospitalet de Llobregat, Spain, Manresa, Spain and 11 additional locations.
Who is sponsoring the NCT06844318 clinical trial?
NCT06844318 is sponsored by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa. The principal investigator is Margalida Calafat, MD, PhD at Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU). The trial plans to enroll 153 participants.