Immunological Characteristics of Preclinical IBD

Launched by GRUPO ESPANOL DE TRABAJO EN ENFERMEDAD DE CROHN Y COLITIS ULCEROSA · Jan 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the immune system characteristics of patients with inflammatory bowel disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. The goal is to understand how the disease progresses, particularly in terms of developing symptoms and complications such as fistulas (abnormal connections between organs), abscesses (pockets of infection), and strictures (narrowing of the intestines).

To participate, you need to be at least 18 years old and have been recently diagnosed with IBD, either through a screening colonoscopy or after showing symptoms. There are different groups in the study based on whether you have no symptoms at diagnosis or if you have just started experiencing symptoms. Participants will undergo evaluations to track their health over time. It’s important to know that anyone with certain gastrointestinal symptoms or who has previously used specific medications for IBD may not be eligible. The trial is currently recruiting participants, and everyone is welcome, regardless of gender.

Gender

ALL

Eligibility criteria

• • 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.