RecruitingNCT05698745
Immunological Characteristics of Preclinical IBD
Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
Sponsor
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Enrollment
450 participants
Start Date
Jun 1, 2024
Study Type
OBSERVATIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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.
Exclusion Criteria7
- 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.
- \- Previous use of immunomodulators or biologics for any condition.
- Any gastrointestinal symptoms at baseline.
- Previous use of immunomodulators or biologics for any condition.
Interventions
PROCEDUREbioespecimen samples
Blood, serum, plasma, urine, stools, small/large bowel tissue.
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT05698745
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