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Crohn DiseaseNCT05698745

Immunological Characteristics of Preclinical IBD

An observational study of Crohn Disease and Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 25 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Crohn Disease, Ulcerative Colitis, IBD
What is being tested?
bioespecimen samples
Type of treatment
Surgery or procedure
How many people
450 participants
Where
25 sitesSpain
Study dates
1 Jun 2024to 1 Jul 2038
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All patients with a new diagnosis of IBD

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Erika Araya, PhD contact

+34 674682070

secretariacientifica3@geteccu.org

Iago Rodriguez Lago, MD contact

+34 674682070

iago.r.lago@gmail.com

25 sites in 1 country

Spain25 sites, 24 recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    Ana Gutiérrez Casbas, MD

    Ana Gutiérrez Casbas, MD

    Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Miriam Mañosa, MD

    Miriam Mañosa, MD

    Not yet recruiting

  • Hospital de Sant Joan Despí Moisès Broggi

    Barcelona, 08970

    Orlando García Bosch, MD

    Orlando García Bosch, MD

    Recruiting

  • Hospital Universitario de Basurto

    Bilbao, 48013

    Jone Ortíz de Zarate, MD

    Jone Ortíz de Zarate, MD

    Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006

    Beatriz Sicilia Aladrén, MD

    Beatriz Sicilia Aladrén, MD

    Not yet recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

    Eva Iglesias Flores, MD

    Eva Iglesias Flores, MD

    Not yet recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

    Horacio Alonso Galán, MD

    Horacio Alonso Galán, MD

    Not yet recruiting

  • Hospital Universitario de Galdakao

    Galdakao, Vizcaya, 48960

    Iago Rodríguez Lago, MD

    Iago Rodríguez Lago, MD

    Recruiting

  • Hospital Universitario de Cabueñes

    Gijón, Principality of Asturias, 33394

    Pilar Varela Trastoy, MD

    Pilar Varela Trastoy, MD

    Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006

    Javier Pérez Gisbert, MD

    Javier Pérez Gisbert, MD

    Not yet recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

    Active, not recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Francisco Mesonero Gismero, MD

    Francisco Mesonero Gismero, MD

    Not yet recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Cristina Suárez Ferrer, MD

    Cristina Suárez Ferrer, MD

    Not yet recruiting

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, Barcelona, 08243

    Empar Sainz Arnau, MD

    Empar Sainz Arnau, MD

    Not yet recruiting

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005

    Coral Tejido Sandoval, MD

    Coral Tejido Sandoval, MD

    Not yet recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Ruth De francisco, MD

    Ruth De francisco, MD

    Not yet recruiting

  • Hospital Universitario de Canarias

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

    Laura Ramos, MD

    Inmaculada Alonso, MD

    Not yet recruiting

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

    Rocío Ferreiro Iglesias, MD

    Rocío Ferreiro Iglesias, MD

    Recruiting

  • Hospital Universitari Mútua de Terrassa

    Terrassa, Barcelona, 08221

    Yamile Zabana Abdo, MD

    Yamile Zabana Abdo, MD

    Not yet recruiting

  • Hospital Universitario Clínico de Valencia

    Valencia, 46010

    Carles Suria Bolufer, MD

    Carles Suria Bolufer, MD

    Not yet recruiting

  • Hospital Univeristario y Politécnico La Fe

    Valencia, 46026

    Mariam Aguas Peris, MD

    Mariam Aguas Peris, MD

    Not yet recruiting

  • Hospital Universitario Río Hortega

    Valladolid, 47012

    Javier García Alonso, MD

    Javier García Alonso, MD

    Not yet recruiting

  • Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)

    Vigo, Pontevedra, 36312

    Natalia Garcia Morales, MD

    Natalia Garcia Morales, MD

    Not yet recruiting

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

    Carla Gargallo Puyuelo, MD

    Carla Gargallo Puyuelo, MD

    Not yet recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Raquel Vicente Lidón, MD

    Raquel Vicente Lidón, MD

    Not yet recruiting

Other trials in Spain

About this study

Official title: Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

Read the detailed description

This is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of IBD, before the onset of the first symptoms of the disease. This novel approach constitutes an innovative strategy on the research on the natural history of the disease. The study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of IBD in this setting. These patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses.

Two additional control groups will be identified, including patients with new-onset symptomatic IBD in the last 3 months and healthy controls (with normal screening colonoscopy).

Being tested
bioespecimen samples
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bioespecimen samplesProcedure or surgery

    Blood, serum, plasma, urine, stools, small/large bowel tissue.

Study groups in NCT05698745
Study groupRoleWhat they receive
Cohort A (preclinical IBD)asymptomatic patients with a new diagnosis of IBD during the colorectal cancer screening programme meeting all inclusion and none of the exclusion criteria (n=350).
Receives: Procedure: bioespecimen samples
Cohort B (control)new-onset symptomatic IBD (n=80) - patients with a symptomatic debut of IBD in the last 3 months, naïve to immunosuppressants and biologic agents.
Receives: Procedure: bioespecimen samples
Cohort C (control)healthy controls (n=20): patients with a normal screening colonoscopy, with no signs of IBD after a detailed evaluation of the ileum and colon, will be included.
Receives: Procedure: bioespecimen samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease progression

    Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding).

    Measured: 10 years

  2. Disease progression

    Time to development of symptomatic disease during follow-up.

    Measured: 10 years

  3. - IBD characteristics

    • Type (CD or UC)
    • Disease extent (CD or UC) according to Montreal classification
    • CD phenotype at diagnosis (Montreal classification)
    • Endoscopic characteristics at diagnosis (both CD and UC): type of lesions, distribution, and extent
    • Presence and type (simple, complex fistula or abscess) of perianal disease at diagnosis and during follow-up

    Measured: 10 years

  4. Omic findings

    proteomic, transcriptomic, serologic, microbiota, and tissue data

    Measured: 10 years

Secondary outcomes (7)

  1. IBD characteristics:

    • Development and time to development of changes in CD disease location, according to Montreal classification.
    • Development and time to development of new-onset or stricturing, penetrating or perianal complications, defined as changes in CD phenotype (Montreal classification)
    • Development of proximal disease extension in UC
    • Laboratory parameters: FOBT levels at diagnosis, and CRP, hemoglobin, albumin, fecal calprotectin at diagnosis and during follow-up.

    Measured: 10 years

  2. Changes in endoscopic features during follow-up

    Measured: 10 years

  3. Microscopic characteristics at diagnosis

    Measured: 10 years

  4. Clinical disease activity during follow-up

    Measured: 10years

  5. Development and time to development of need for medical or surgical therapy during follow-up

    Measured: 10years

  6. Development and time to development of extraintestinal manifestations during follow-up

    Measured: 10years

  7. Type of extraintestinal manifestations during follow-up

    Measured: 10years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start1 Jun 2024
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2038 (estimated)

Resources

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
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698745
Sponsor's protocol ID
EARLY
Status last verified
Apr 2026
First submitted
10 Jan 2023
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rodriguez-Lago I, Marigorta UM, Mateos B, Manosa M, Marquez-Mosquera L, Menchen L, Rodriguez-Moranta F, Alonso I, Aguas M, Alonso-Galan H, Borras P, Castro B, Domenech E, Ferreiro-Iglesias R, de Francisco R, Garcia-Alonso FJ, Garcia N, Garcia-Bosch O, Gargallo C, Gisbert JP, Iglesias E, Mesonero F, Ortiz de Zarate J, Ramos L, Sainz E, Ladron P, Suria C, Ferrer CS, Tejido C, Varela P, Vicente R, Zabana Y, Castany G, Rodriguez E, Gutierrez A, Barreiro-de Acosta M. Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study. Ther Adv Gastroenterol. 2025 May 12;18:17562848251338647. doi: 10.1177/17562848251338647. eCollection 2025.

    PubMed 40365077

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn Disease and Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 25 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 14 inclusion and 10 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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, PhD (+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?

Disease progression (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698745, which also lists 1 linked publication.

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 15 Apr 2026.

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