Immunological Characteristics of Preclinical IBD (NCT05698745) | Clinical Trial Compass
RecruitingNot Applicable
Immunological Characteristics of Preclinical IBD
Spain450 participantsStarted 2024-06-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 microsc…
What they're measuring
1
Disease progression
Timeframe: 10 years
2
Disease progression
Timeframe: 10 years
3
- IBD characteristics
Timeframe: 10 years
4
Omic findings
Timeframe: 10 years
Trial details
NCT IDNCT05698745
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa