NCT05698745 Immunological Characteristics of Preclinical IBD
| NCT ID | NCT05698745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2024-06-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Iago Rodriguez Lago, MD
PRINCIPAL INVESTIGATOR
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Frequently Asked Questions
Who can join the NCT05698745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05698745 currently recruiting?
Yes, NCT05698745 is actively recruiting participants. Contact the research team at secretariacientifica3@geteccu.org for enrollment information.
Where is the NCT05698745 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Badalona, Spain, Manresa, Spain, Terrassa, Spain and 11 additional locations.
Who is sponsoring the NCT05698745 clinical trial?
NCT05698745 is sponsored by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa. The principal investigator is Iago Rodriguez Lago, MD at Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU). The trial plans to enroll 450 participants.