IBDFRAGILNCT06844318
Impact of IBD Activity on Frailty in Patients Over 60 Years
An observational study of IBD, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 34 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- IBD
- How many people
- 153 participants
- Where
- 34 sitesSpain
- Study dates
- 14 Apr 2025to May 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Casas contact
34 sites in 1 country
Spain34 sites, 34 recruiting
- Recruiting
Hospital Dr Balmis
Alicante, Valencia
Lucía Madero, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Complejo Asistencial de Ávila
Ávila
Rosanna Villanueva, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital San Agustín de Avilés
Avilés, Principality of Asturias
Pelayo Rodríguez, MD, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona
Margalida Calafat, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Esther Garcia-Planella, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Universitario de Burgos
Burgos
Beatriz Sicilia, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Denia
Denia, Valencia
Ana Crespo, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital de Cabueñes
Gijón, Principality of Asturias
Pilar Varela, MD, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Universitari Dr Josep Trueta
Girona
David Busquets, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Juan Ramón Jiménez
Huelva
Elena Gómez, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Alexandra Ruiz, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas
Daniel Ceballos, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Universitario Lucus Augusti
Lugo
Alina López, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Infanta Elena
Madrid, 28342
Esteban Fuentes Valenzuela, MD, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Puerta de Hierro Majadahonda
Madrid
Marta Calvo, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Ramon y Cajal
Madrid
Júlia López, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Universitario Infanta Leonor
Madrid
Ángel Ponferrada, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Althaia Manresa
Manresa, Barcelona
Marta Teller, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital del Mataró
Mataró, Barcelona
Manuela Sampedro González, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Complexo Hospitalario Universitario de Ourense
Ourense
Cristina Alejandra Sánchez Gómez, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Universitario Central de Astúrias
Oviedo, Principality of Asturias
Lorena Cargallo, MD, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife
Marta Carrillo, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Royo Villanova
San Gregorio, Zaragoza
Patrícia Sanz, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital de Henares
San Sebastián de los Reyes, Madrid
Maricarmen Grau, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife
Ángel Febles, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona
David Monfort Miquel, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Mútua de Terrassa
Terrassa, Barcelona
Pere Borràs, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital de Toledo
Toledo, Castille-La Mancha
Pelayo Rodríguez, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Sierrallana de Torrelavega
Torrelavega, Cantabria
Célia Ruiz, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital General Universitario de Valencia
Valencia
Jose Mª Huguet, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Universitario de la Fe
Valencia
Marisa Iborra, 635899553, secretariacientifica2@geteccu.org
- Recruiting
Hospital Viladecans
Viladecans, Barcelona
Pau Gilabert, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, 01009
Patricia Ramirez de la Piscina, +34 674682070, secretariacientifica3@geteccu.org
- Recruiting
Hospital Lozano Blesa
Zaragoza
Yolanda Ber, 635899553, secretariacientifica2@geteccu.org
About this study
Official title: Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
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:
- 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?
- 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.
Read the detailed 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.
- Conditions
- IBD
- Keywords
- eldearly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity | Patients aged ≥60 years with a diagnosis of inflamatory bowel disease (IBD) and clinical and/or biological disease activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.
The evaluation of the impact of IBD activity will be measured by Patient Reported outcomes 2 (PRO-2).
IBD clinical activity measured by PRO-2 for Crohn's disease (CD) is composed by:
CD-PRO2: number of liquid daily stools and abdominal pain (0=none; 1=low; 2= moderate; 3= severe).
IBD clinical activity measured by PRO-2 for ulcerative colitis (UC) is composed of 2 parts:
UC-PRO2: stool number respect basal (0 =normal, same as usual; 1 = 1-2 stools more than the usual; 2 = 3-4 stools more than the usual; 3 = 5 or more stools more than the usual) and rectal bleeding (0 = none; 1 = visible blood in fences at least in half of them; 2 = visible blood in fences > half of them or mores; 3 = only blood).
Clinic-biological activity: PRO2>4 in UC; PRO2>14 in CD
Measured: 12 months
To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.
The assessment of the impact of frailty will be measured by Fried Index. Fried Index is composed by a sum up of 5 parts, that follows:
Unintended weight loss (score 0-1), Self-reported fatigue (score 0-1), Creep speed (score 0-1), Low physical activity (score 0-1), Weakness (score 0-1),
The result of the total score is: Frail 3-5 points, pre- frail 1-2 points, "fit" 0 points.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start14 Apr 2025
- Primary completionJul 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margalida Calafat, MD, PhD, Principal investigator, Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844318
- Sponsor's protocol ID
- FRAGIL
- Acronym
- FRAGIL
- Status last verified
- May 2026
- First submitted
- 3 Feb 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
- ClinicalTrials.gov ID
- NCT06844318
- Acronym / sponsor ID
- FRAGIL / FRAGIL
- Conditions
- IBD
- Keywords
- eldearly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity | – | –Patients aged ≥60 years with a diagnosis of inflamatory bowel disease (IBD) and clinical and/or biological disease activity |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.
Time frame: 12 months
The evaluation of the impact of IBD activity will be measured by Patient Reported outcomes 2 (PRO-2). IBD clinical activity measured by PRO-2 for Crohn's disease (CD) is composed by: CD-PRO2: number of liquid daily stools and abdominal pain (0=none; 1=low; 2= moderate; 3= severe). IBD clinical activity measured by PRO-2 for ulcerative colitis (UC) is composed of 2 parts: UC-PRO2: stool number respect basal (0 =normal, same as usual; 1 = 1-2 stools more than the usual; 2 = 3-4 stools more than the usual; 3 = 5 or more stools more than the usual) and rectal bleeding (0 = none; 1 = visible blood in fences at least in half of them; 2 = visible blood in fences > half of them or mores; 3 = only blood). Clinic-biological activity: PRO2>4 in UC; PRO2>14 in CD
To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.
Time frame: 12 months
The assessment of the impact of frailty will be measured by Fried Index. Fried Index is composed by a sum up of 5 parts, that follows: Unintended weight loss (score 0-1), Self-reported fatigue (score 0-1), Creep speed (score 0-1), Low physical activity (score 0-1), Weakness (score 0-1), The result of the total score is: Frail 3-5 points, pre- frail 1-2 points, "fit" 0 points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Related trials for IBD
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Casas contact
Margalida Calafat, MD, PhD principal investigator
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 34 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Araya (+34 674682070, secretariacientifica3@geteccu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.