Immunological Characteristics of Preclinical IBD
Recruiting · NCT05698745 · Observational (researchers observe without assigning treatment) · Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
View the official record on ClinicalTrials.gov →Interventions studied
bioespecimen samples
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
25 locations listed.
- Hospital General Universitario Dr. Balmis - Alicante, Spain
- Hospital de Sant Joan Despí Moisès Broggi - Barcelona, Spain
- Hospital Universitario de Basurto - Bilbao, Spain
- Hospital Universitario de Burgos - Burgos, Spain
- Hospital Universitario Reina Sofía - Córdoba, Spain
- Hospital Universitario de la Princesa - Madrid, Spain
- Hospital General Universitario Gregorio Marañón - Madrid, Spain
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Complejo Hospitalario Universitario de Ourense - Ourense, Spain
- Hospital Universitario Clínico de Valencia - Valencia, Spain
- Hospital Univeristario y Politécnico La Fe - Valencia, Spain
- Hospital Universitario Río Hortega - Valladolid, Spain
- Hospital Clínico Universitario Lozano Blesa - Zaragoza, Spain
- Hospital Universitario Miguel Servet - Zaragoza, Spain
- Hospital Clínico Universitario de Santiago - Santiago de Compostela, A Coruña, Spain
- Hospital Universitario Germans Trias i Pujol - Badalona, Barcelona, Spain
- Althaia, Xarxa Assistencial Universitària de Manresa - Manresa, Barcelona, Spain
- Hospital Universitari Mútua de Terrassa - Terrassa, Barcelona, Spain
- Hospital Universitario Donostia - Donostia / San Sebastian, Gipuzkoa, Spain
- Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) - Vigo, Pontevedra, Spain
- Hospital Universitario de Cabueñes - Gijón, Principality of Asturias, Spain
- Hospital Universitario Central de Asturias - Oviedo, Principality of Asturias, Spain
- Hospital Universitario de Canarias - San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
- Hospital Universitario de Galdakao - Galdakao, Vizcaya, Spain