Impact of IBD Activity on Frailty in Patients Over 60 Years

Last updated: May 6, 2026
Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT06844318
FRAGIL
  • Ages > 60
  • All Genders

Study 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

Inclusion Criteria:

  • Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosedaccording to ECCO criteria and under follow-up in the IBD units of participatingcenters.

  • Initiation of medical treatment (oral mesalazine, topical or systemiccorticosteroids, immunosuppressants, and/or biologics) due to clinical activitybased on PRO2 scales (UC: PRO >4; CD: PRO2 >14) and/or biological activity (fecalcalprotectin ≥500 mg/kg, C-reactive protein ≥10 mg/L).

  • Signed informed consent for inclusion.

Exclusion

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 diseaseactivity.

  • Treatment intensification to manage disease activity.

  • Patients with an ostomy.

  • Comorbidities with a life expectancy of less than one year.

Study Design

Total Participants: 153
Study Start date:
April 14, 2025
Estimated Completion Date:
May 31, 2027

Study Description

All consecutive patients meeting the selection criteria in the participating centres will be invited to participate.

-At inclusion, 4 clinical frailty indices (CFS-Clinical Frailty Scale, FRAGIL-VIG, Fried, VES-13) will be calculated. In addition, clinical variables on IBD (diagnosis, phenotype, extraintestinal manifestations, perianal disease, time of evolution of the disease, active treatments at the time of inclusion, treatment initiated, diagnostic tests available at the time of inclusion) and comorbidities (allowing calculation of the Charlson and Cumulative Illness Rating Scale for Geriatriscs [CIRS-G] indices) will be recorded.

Follow-up: a total of 3 follow-up visits will be conducted (at 3, 6 and 12 months) where frailty, comorbidities, IBD activity, changes in IBD medical treatment, adverse effects, hospitalisations and mortality will be reassessed.

Connect with a study center

  • Hospital Universitario Araba

    Vitoria, Alava 01009
    Spain

    Site Not Available

  • Hospital Universitario Araba

    Vitoria-Gasteiz, Alava 01009
    Spain

    Active - Recruiting

  • Hospital Universitario Araba

    Vitoria-Gasteiz 3104499, Alava 01009
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona
    Spain

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona 3129028, Barcelona
    Spain

    Site Not Available

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat 3120619, Barcelona
    Spain

    Site Not Available

  • Althaia Manresa

    Manresa, Barcelona
    Spain

    Active - Recruiting

  • Althaia Manresa

    Manresa 3117533, Barcelona
    Spain

    Site Not Available

  • Hospital del Mataró

    Mataró, Barcelona
    Spain

    Active - Recruiting

  • Hospital del Mataró

    Mataró 3117164, Barcelona
    Spain

    Site Not Available

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona
    Spain

    Active - Recruiting

  • Hospital Mútua de Terrassa

    Terrassa, Barcelona
    Spain

    Active - Recruiting

  • Consorci Sanitari de Terrassa

    Terrassa 3108286, Barcelona
    Spain

    Site Not Available

  • Hospital Mútua de Terrassa

    Terrassa 3108286, Barcelona
    Spain

    Active - Recruiting

  • Hospital Viladecans

    Viladecans, Barcelona
    Spain

    Active - Recruiting

  • Hospital Viladecans

    Viladecans 3105935, Barcelona
    Spain

    Site Not Available

  • Hospital Sierrallana de Torrelavega

    Torrelavega, Cantabria
    Spain

    Active - Recruiting

  • Hospital Sierrallana de Torrelavega

    Torrelavega 3107775, Cantabria 3336898
    Spain

    Site Not Available

  • Hospital de Toledo

    Toledo, Castille-La Mancha
    Spain

    Active - Recruiting

  • Hospital de Toledo

    Toledo 2510409, Castille-La Mancha 2593111
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria 2515270, Las Palmas
    Spain

    Site Not Available

  • Hospital de Henares

    San Sebastián de los Reyes, Madrid
    Spain

    Active - Recruiting

  • Hospital de Henares

    San Sebastián de los Reyes 3110040, Madrid 3117732
    Spain

    Site Not Available

  • Hospital San Agustín de Avilés

    Avilés, Principality of Asturias
    Spain

    Active - Recruiting

  • Hospital de Cabueñes

    Gijón, Principality of Asturias
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Astúrias

    Oviedo, Principality of Asturias
    Spain

    Active - Recruiting

  • Hospital San Agustín de Avilés

    Avilés 3129135, Principality of Asturias 3114710
    Spain

    Site Not Available

  • Hospital de Cabueñes

    Gijón 3121424, Principality of Asturias 3114710
    Spain

    Site Not Available

  • Hospital Universitario Central de Astúrias

    Oviedo 3114711, Principality of Asturias 3114710
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    La Laguna, Santa Cruz De Tenerife
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna 2511401, Santa Cruz De Tenerife
    Spain

    Site Not Available

  • Hospital Dr Balmis

    Alicante, Valencia
    Spain

    Active - Recruiting

  • Hospital Denia

    Denia, Valencia
    Spain

    Active - Recruiting

  • Hospital Dr Balmis

    Alicante 2521978, Valencia 2593113
    Spain

    Site Not Available

  • Hospital Denia

    Denia 2518878, Valencia 2593113
    Spain

    Site Not Available

  • Hospital Royo Villanova

    San Gregorio, Zaragoza
    Spain

    Active - Recruiting

  • Hospital Royo Villanova

    San Gregorio 3110596, Zaragoza
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760,
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos,
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos 3127461,
    Spain

    Site Not Available

  • Hospital Universitari Dr Josep Trueta

    Girona,
    Spain

    Active - Recruiting

  • Hospital Universitari Dr Josep Trueta

    Girona 3121456,
    Spain

    Site Not Available

  • Hospital Juan Ramón Jiménez

    Huelva,
    Spain

    Active - Recruiting

  • Hospital Juan Ramón Jiménez

    Huelva 2516548,
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo,
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo 3117814,
    Spain

    Site Not Available

  • Hospital Infanta Elena

    Madrid, 28342
    Spain

    Active - Recruiting

  • Hospital Puerta de Hierro Majadahonda

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Puerta de Hierro Majadahonda

    Madrid 3117735,
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense,
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense 3114965,
    Spain

    Site Not Available

  • Hospital Universitario Ntra. Sra. de Candelaria

    Santa Cruz de Tenerife,
    Spain

    Active - Recruiting

  • Hospital Universitario Ntra. Sra. de Candelaria

    Santa Cruz de Tenerife 2511174,
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Universitario de la Fe

    Valencia,
    Spain

    Active - Recruiting

  • Hospital General Universitario de Valencia

    Valencia 2509954,
    Spain

    Active - Recruiting

  • Hospital Universitario de la Fe

    Valencia 2509954,
    Spain

    Site Not Available

  • Hospital Lozano Blesa

    Zaragoza,
    Spain

    Active - Recruiting

  • Hospital Lozano Blesa

    Zaragoza 3104324,
    Spain

    Site Not Available

  • Complejo Asistencial de Ávila

    Ávila,
    Spain

    Active - Recruiting

  • Complejo Asistencial de Ávila

    Ávila 3129136,
    Spain

    Site Not Available

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