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Scientists track hidden gut disease in 450 asymptomatic patients

NCT ID NCT05698745

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 450 adults who have early signs of inflammatory bowel disease (Crohn's or ulcerative colitis) found during routine colon cancer screening, but who have no symptoms yet. Researchers will collect blood, stool, and tissue samples over time to see how the disease progresses and who develops symptoms. The goal is to better understand the natural history of preclinical IBD.

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 study could help doctors predict who will develop inflammatory bowel disease and possibly prevent it.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to any direct medical benefit for participants.

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 450 people

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

Started

Jun 2024

Expected to finish

Jul 2038

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

All patients with a new diagnosis of IBD

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 from cohort A will be included if they fulfill all the following inclusion criteria: * Male or female ≥18 years of age at baseline. * New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34). * Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD. * The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD. * Time interval between the index colonoscopy and the baseline visit up to 3 months. Patients from cohort B will be included if they fulfill all the following inclusion criteria: * Male or female ≥18 years of age at baseline. * Recent diagnosis of IBD, with \<3 months from symptoms onset. * Time interval between the index colonoscopy and the baseline visit up to 3 months. Patients from cohort C will be included if they fulfill all the following inclusion criteria: * Male or female ≥18 years of age at baseline. * No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program. * Time interval between the index colonoscopy and the baseline visit up to 3 months. Exclusion criteria Patients from cohort A will be excluded if they fulfill any the following exclusion criteria: * Identification of any enteropathogen in the stool culture. * Isolated findings of acute inflammatory infiltrate without signs of chronicity. * Previous or current diagnosis of microscopic colitis. * Alteration in biomarkers in blood or stool will not constitute an exclusion criterion. Patients from cohort B will be excluded if they fulfill any the following exclusion criteria: \- Previous use of immunomodulators or biologics for any condition. Patients from cohort C will be excluded if they fulfill any the following exclusion criteria: * Any gastrointestinal symptoms at baseline. * Previous use of immunomodulators or biologics for any condition.

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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.

Crohn disease IBD Ulcerative colitis

How to take part

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

  1. The places running it

    24 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, Xarxa Assistencial Universitària de Manresa

    NOT_YET_RECRUITING

    Manresa, Barcelona, 08243, Spain

  • Complejo Hospitalario Universitario de Ourense

    NOT_YET_RECRUITING

    Ourense, 32005, Spain

  • Hospital Clínico Universitario Lozano Blesa

    NOT_YET_RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Clínico Universitario de Santiago

    RECRUITING

    Santiago de Compostela, A Coruña, 15706, Spain

  • Hospital General Universitario Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hospital General Universitario Gregorio Marañón

    ACTIVE_NOT_RECRUITING

    Madrid, 28007, Spain

  • Hospital Univeristario y Politécnico La Fe

    NOT_YET_RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitari Mútua de Terrassa

    NOT_YET_RECRUITING

    Terrassa, Barcelona, 08221, Spain

  • Hospital Universitario Central de Asturias

    NOT_YET_RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Clínico de Valencia

    NOT_YET_RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario Donostia

    NOT_YET_RECRUITING

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Hospital Universitario Germans Trias i Pujol

    NOT_YET_RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario La Paz

    NOT_YET_RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    NOT_YET_RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramon y Cajal

    NOT_YET_RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    NOT_YET_RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Río Hortega

    NOT_YET_RECRUITING

    Valladolid, 47012, Spain

  • Hospital Universitario de Basurto

    RECRUITING

    Bilbao, 48013, Spain

  • Hospital Universitario de Burgos

    NOT_YET_RECRUITING

    Burgos, 09006, Spain

  • Hospital Universitario de Cabueñes

    RECRUITING

    Gijón, Principality of Asturias, 33394, Spain

  • Hospital Universitario de Canarias

    NOT_YET_RECRUITING

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Hospital Universitario de Galdakao

    RECRUITING

    Galdakao, Vizcaya, 48960, Spain

  • Hospital Universitario de la Princesa

    NOT_YET_RECRUITING

    Madrid, 28006, Spain

  • Hospital de Sant Joan Despí Moisès Broggi

    RECRUITING

    Barcelona, 08970, Spain

  • Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)

    NOT_YET_RECRUITING

    Vigo, Pontevedra, 36312, Spain

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