Actively Recruiting

Age: 60Years +
All Genders
NCT06844318

Impact of IBD Activity on Frailty in Patients Over 60 Years

Led by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Updated on 2026-05-07

153

Participants Needed

34

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Impact of IBD Activity on Frailty in Patients Over 60 Years

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 60 years or older with inflammatory bowel disease (Crohn's disease or ulcerative colitis) diagnosed by ECCO criteria and followed in participating IBD units
  • Starting medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to active disease based on clinical symptoms or biological markers
  • Signed informed consent for participation
Not Eligible

You will not qualify if you...

  • Lack or withdrawal of informed consent
  • Diagnosis of unclassified or indeterminate colitis
  • Change in medical treatment only because of adverse events
  • Starting treatment only with salicylates and/or topical steroids for disease activity
  • Treatment intensification used to manage disease activity
  • Presence of an ostomy
  • Comorbidities with life expectancy less than one year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 34 locations

1

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain, 01009

Actively Recruiting

2

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Actively Recruiting

3

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Actively Recruiting

4

Althaia Manresa

Manresa, Barcelona, Spain

Actively Recruiting

5

Hospital del Mataró

Mataró, Barcelona, Spain

Actively Recruiting

6

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Actively Recruiting

7

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

Actively Recruiting

8

Hospital Viladecans

Viladecans, Barcelona, Spain

Actively Recruiting

9

Hospital Sierrallana de Torrelavega

Torrelavega, Cantabria, Spain

Actively Recruiting

10

Hospital de Toledo

Toledo, Castille-La Mancha, Spain

Actively Recruiting

11

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Actively Recruiting

12

Hospital de Henares

San Sebastián de los Reyes, Madrid, Spain

Actively Recruiting

13

Hospital San Agustín de Avilés

Avilés, Principality of Asturias, Spain

Actively Recruiting

14

Hospital de Cabueñes

Gijón, Principality of Asturias, Spain

Actively Recruiting

15

Hospital Universitario Central de Astúrias

Oviedo, Principality of Asturias, Spain

Actively Recruiting

16

Hospital Universitario de Canarias

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

Actively Recruiting

17

Hospital Dr Balmis

Alicante, Valencia, Spain

Actively Recruiting

18

Hospital Denia

Denia, Valencia, Spain

Actively Recruiting

19

Hospital Royo Villanova

San Gregorio, Zaragoza, Spain

Actively Recruiting

20

Complejo Asistencial de Ávila

Ávila, Spain

Actively Recruiting

21

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Actively Recruiting

22

Hospital Universitario de Burgos

Burgos, Spain

Actively Recruiting

23

Hospital Universitari Dr Josep Trueta

Girona, Spain

Actively Recruiting

24

Hospital Juan Ramón Jiménez

Huelva, Spain

Actively Recruiting

25

Hospital Universitario Lucus Augusti

Lugo, Spain

Actively Recruiting

26

Hospital Infanta Elena

Madrid, Spain, 28342

Actively Recruiting

27

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Actively Recruiting

28

Hospital Ramon y Cajal

Madrid, Spain

Actively Recruiting

29

Hospital Universitario Infanta Leonor

Madrid, Spain

Actively Recruiting

30

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

Actively Recruiting

31

Hospital Universitario Ntra. Sra. de Candelaria

Santa Cruz de Tenerife, Spain

Actively Recruiting

32

Hospital General Universitario de Valencia

Valencia, Spain

Actively Recruiting

33

Hospital Universitario de la Fe

Valencia, Spain

Actively Recruiting

34

Hospital Lozano Blesa

Zaragoza, Spain

Actively Recruiting

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Research Team

E

Erika Araya

CONTACT

A

Anna Casas

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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