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How IBD activity affects frailty in people aged 60 and older

Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years

Observational Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · NCT06844318

This project will see if active IBD worsens frailty and whether treating activity can reduce frailty and the risk of hospitalization or death in people aged 60 and up.

Quick facts

Study typeObservational
Enrollment153 (estimated)
Ages60 Years and up
SexAll
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Academic / other
Locations34 sites (Vitoria-Gasteiz, Alava and 33 other locations)
Trial IDNCT06844318 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 60 or older with Crohn's disease or ulcerative colitis (per ECCO criteria) who are under follow-up at a participating IBD unit and are starting medical treatment for clinically or biologically active disease and can give informed consent.

Not a fit: Patients with unclassified colitis, an ostomy, those whose treatment change is only for adverse events, those starting only topical/salicylate therapy, or with life expectancy under one year are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this work could help clinicians identify older IBD patients at highest risk and guide treatment to reduce hospitalizations and deaths by targeting reversible frailty.

How similar studies have performed: Previous observational research has linked frailty to worse outcomes in older IBD and other chronic disease populations, but longitudinal data on reversibility with treatment and head-to-head comparisons of frailty indices in IBD are limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Vitoria-Gasteiz, Alava and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions IBDeldearly
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.