Immunological Characteristics of Preclinical IBD
Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
1 other identifier
observational
450
1 country
25
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2038
April 15, 2026
April 1, 2026
2.1 years
January 10, 2023
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
IBD characteristics:
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
- +2 more secondary outcomes
Study Arms (3)
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).
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.
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.
Interventions
Blood, serum, plasma, urine, stools, small/large bowel tissue.
Eligibility Criteria
All patients with a new diagnosis of IBD
You may qualify if:
- 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.
- 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.
- 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.
You may not qualify if:
- 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.
- \- Previous use of immunomodulators or biologics for any condition.
- Any gastrointestinal symptoms at baseline.
- Previous use of immunomodulators or biologics for any condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
Vigo, Pontevedra, 36312, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, 33394, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital Universitario de Galdakao
Galdakao, Vizcaya, 48960, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital de Sant Joan Despí Moisès Broggi
Barcelona, 08970, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, 32005, Spain
Hospital Universitario Clínico de Valencia
Valencia, 46010, Spain
Hospital Univeristario y Politécnico La Fe
Valencia, 46026, Spain
Hospital Universitario Río Hortega
Valladolid, 47012, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Related Publications (1)
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.
PMID: 40365077RESULT
Biospecimen
Blood, serum, plasma, urine, stools, small/large bowel tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iago Rodriguez Lago, MD
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2023
First Posted
January 26, 2023
Study Start
June 1, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2038
Last Updated
April 15, 2026
Record last verified: 2026-04