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Study to uncover link between IBD and frailty in seniors

NCT ID NCT06844318

Knowledge-focused Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 153 people aged 60 and older with inflammatory bowel disease (IBD) to see how disease activity affects frailty. Researchers will also check whether frailty raises the risk of hospitalization or death. Participants will have their frailty, IBD symptoms, and overall health tracked over time using simple questionnaires and tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify frail older IBD patients earlier and tailor treatment to reduce complications.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged ≥60 years with a diagnosis of IBD and clinical and/or biological disease activity.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IBD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Althaia Manresa

    RECRUITING

    Manresa, Barcelona, Spain

  • Complejo Asistencial de Ávila

    RECRUITING

    Ávila, Spain

  • Complexo Hospitalario Universitario de Ourense

    RECRUITING

    Ourense, Spain

  • Consorci Sanitari de Terrassa

    RECRUITING

    Terrassa, Barcelona, Spain

  • Hospital Denia

    RECRUITING

    Denia, Valencia, Spain

  • Hospital Dr Balmis

    RECRUITING

    Alicante, Valencia, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, Spain

  • Hospital Infanta Elena

    RECRUITING

    Madrid, 28342, Spain

  • Hospital Juan Ramón Jiménez

    RECRUITING

    Huelva, Spain

  • Hospital Lozano Blesa

    RECRUITING

    Zaragoza, Spain

  • Hospital Mútua de Terrassa

    RECRUITING

    Terrassa, Barcelona, Spain

  • Hospital Puerta de Hierro Majadahonda

    RECRUITING

    Madrid, Spain

  • Hospital Ramon y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Royo Villanova

    RECRUITING

    San Gregorio, Zaragoza, Spain

  • Hospital San Agustín de Avilés

    RECRUITING

    Avilés, Principality of Asturias, Spain

  • Hospital Sierrallana de Torrelavega

    RECRUITING

    Torrelavega, Cantabria, Spain

  • Hospital Universitari Dr Josep Trueta

    RECRUITING

    Girona, Spain

  • Hospital Universitario Araba

    RECRUITING

    Vitoria-Gasteiz, Alava, 01009, Spain

  • Hospital Universitario Central de Astúrias

    RECRUITING

    Oviedo, Principality of Asturias, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Spain

  • Hospital Universitario Ntra. Sra. de Candelaria

    RECRUITING

    Santa Cruz de Tenerife, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, Spain

  • Hospital Universitario de Canarias

    RECRUITING

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

  • Hospital Universitario de Gran Canaria Doctor Negrín

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, Spain

  • Hospital Universitario de la Fe

    RECRUITING

    Valencia, Spain

  • Hospital Viladecans

    RECRUITING

    Viladecans, Barcelona, Spain

  • Hospital de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, Spain

  • Hospital de Cabueñes

    RECRUITING

    Gijón, Principality of Asturias, Spain

  • Hospital de Henares

    RECRUITING

    San Sebastián de los Reyes, Madrid, Spain

  • Hospital de Toledo

    RECRUITING

    Toledo, Castille-La Mancha, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

  • Hospital del Mataró

    RECRUITING

    Mataró, Barcelona, Spain

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