Immunological Characteristics of Preclinical IBD (EARLY)

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).

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Ulcerative Colitis; IBD
• Intervention / Treatment: Procedure: bioespecimen samples

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).

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Iago Rodriguez Lago, MD; Phone Number: +34 674682070; Email: iago.r.lago@gmail.com
• Study Contact Backup: Name: Erika Araya, PhD; Phone Number: +34 674682070; Email: secretariacientifica3@geteccu.org

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario Dr. Balmis
    • Contact: Ana Gutiérrez Casbas, MD
    • Principal Investigator: Ana Gutiérrez Casbas, MD
  • Barcelona, Spain, 08970
    • Recruiting
    • Hospital de Sant Joan Despí Moisès Broggi
    • Contact: Orlando García Bosch, MD
    • Principal Investigator: Orlando García Bosch, MD
  • Bilbao, Spain, 48013
    • Recruiting
    • Hospital Universitario de Basurto
    • Contact: Jone Ortíz de Zarate, MD
    • Principal Investigator: Jone Ortíz de Zarate, MD
  • Burgos, Spain, 09006
    • Not yet recruiting
    • Hospital Universitario de Burgos
    • Contact: Beatriz Sicilia Aladrén, MD
    • Principal Investigator: Beatriz Sicilia Aladrén, MD
  • Córdoba, Spain, 14004
    • Not yet recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Eva Iglesias Flores, MD
    • Principal Investigator: Eva Iglesias Flores, MD
  • Madrid, Spain, 28034
    • Not yet recruiting
    • Hospital Universitario Ramón y Cajal
    • Contact: Francisco Mesonero Gismero, MD
    • Principal Investigator: Francisco Mesonero Gismero, MD
  • Madrid, Spain, 28046
    • Not yet recruiting
    • Hospital Universitario La Paz
    • Contact: Cristina Suárez Ferrer, MD
    • Principal Investigator: Cristina Suárez Ferrer, MD
  • Madrid, Spain, 28007
    • Active, not recruiting
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28006
    • Not yet recruiting
    • Hospital Universitario de la Princesa
    • Contact: Javier Pérez Gisbert, MD
    • Principal Investigator: Javier Pérez Gisbert, MD
  • Ourense, Spain, 32005
    • Not yet recruiting
    • Complejo Hospitalario Universitario de Ourense
    • Contact: Coral Tejido Sandoval, MD
    • Principal Investigator: Coral Tejido Sandoval, MD
  • Valencia, Spain, 46010
    • Not yet recruiting
    • Hospital Universitario Clínico de Valencia
    • Contact: Carles Suria Bolufer, MD
    • Principal Investigator: Carles Suria Bolufer, MD
  • Valencia, Spain, 46026
    • Not yet recruiting
    • Hospital Univeristario y Politécnico La Fe
    • Contact: Mariam Aguas Peris, MD
    • Principal Investigator: Mariam Aguas Peris, MD
  • Valladolid, Spain, 47012
    • Not yet recruiting
    • Hospital Universitario Rio Hortega
    • Contact: Javier García Alonso, MD
    • Principal Investigator: Javier García Alonso, MD
  • Zaragoza, Spain, 50009
    • Not yet recruiting
    • Hospital Universitario Miguel Servet
    • Principal Investigator: Raquel Vicente Lidón, MD
    • Contact: Raquel Vicente Lidón, MD
  • Zaragoza, Spain, 50009
    • Not yet recruiting
    • Hospital Clinico Universitario Lozano Blesa
    • Contact: Carla Gargallo Puyuelo, MD
    • Principal Investigator: Carla Gargallo Puyuelo, MD
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Recruiting
      • Hospital Clínico Universitario de Santiago
      • Contact: Rocío Ferreiro Iglesias, MD
      • Principal Investigator: Rocío Ferreiro Iglesias, MD
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Not yet recruiting
      • Hospital Universitario Germans Trias i Pujol
      • Contact: Miriam Mañosa, MD
      • Principal Investigator: Miriam Mañosa, MD
    • Manresa, Barcelona, Spain, 08243
      • Not yet recruiting
      • Althaia, Xarxa Assistencial Universitària de Manresa
      • Principal Investigator: Empar Sainz Arnau, MD
      • Contact: Empar Sainz Arnau, MD
    • Terrassa, Barcelona, Spain, 08221
      • Not yet recruiting
      • Hospital Universitari Mutua de Terrassa
      • Contact: Yamile Zabana Abdo, MD
      • Principal Investigator: Yamile Zabana Abdo, MD
  • Gipuzkoa
    • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
      • Not yet recruiting
      • Hospital Universitario Donostia
      • Contact: Horacio Alonso Galán, MD
      • Principal Investigator: Horacio Alonso Galán, MD
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Not yet recruiting
      • Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
      • Contact: Natalia Garcia Morales, MD
      • Principal Investigator: Natalia Garcia Morales, MD
  • Principality of Asturias
    • Gijón, Principality of Asturias, Spain, 33394
      • Recruiting
      • Hospital Universitario de Cabueñes
      • Contact: Pilar Varela Trastoy, MD
      • Principal Investigator: Pilar Varela Trastoy, MD
    • Oviedo, Principality of Asturias, Spain, 33011
      • Not yet recruiting
      • Hospital Universitario Central de Asturias
      • Contact: Ruth De francisco, MD
      • Principal Investigator: Ruth De francisco, MD
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Not yet recruiting
      • Hospital Universitario de Canarias
      • Principal Investigator: Laura Ramos, MD
      • Contact: Laura Ramos, MD
      • Principal Investigator: Inmaculada Alonso, MD
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Recruiting
      • Hospital Universitario de Galdakao
      • Principal Investigator: Iago Rodríguez Lago, MD
      • Contact: Iago Rodríguez Lago, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients with a new diagnosis of IBD

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: bioespecimen samples; Blood, serum, plasma, urine, stools, small/large bowel tissue.
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.	Procedure: bioespecimen samples; Blood, serum, plasma, urine, stools, small/large bowel tissue.
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.	Procedure: bioespecimen samples; Blood, serum, plasma, urine, stools, small/large bowel tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding).	10 years
Disease progression	Time to development of symptomatic disease during follow-up.	10 years
- 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	10 years
Omic findings	proteomic, transcriptomic, serologic, microbiota, and tissue data	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years
Changes in endoscopic features during follow-up		10 years
Microscopic characteristics at diagnosis		10 years
Clinical disease activity during follow-up		10years
Development and time to development of need for medical or surgical therapy during follow-up		10years
Development and time to development of extraintestinal manifestations during follow-up		10years
Type of extraintestinal manifestations during follow-up		10years

Collaborators and Investigators

• Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Investigators: Principal Investigator: Iago Rodriguez Lago, MD, Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2038

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: EARLY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No