Immunological Characteristics of Preclinical IBD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- bioespecimen samples
Treatment groups
450 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov