Recruiting NCT06580418
Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional biopsies and blood samples.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease. The main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.
Interventions
- Other Additional biopsies and blood samples
During the endoscopic procedure planned for IBD patients following standard clinical practice, the endoscopist will decide the number and location of additional biopsy samples (up to 8) collected for the study. Participation in this study also requires the removal of three additional blood samples.
Primary outcome measures
- Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist [Time frame: 20 months]
Secondary outcome measures (2)
- Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound [Time frame: 26 months]
- Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound [Time frame: 26 months]
Eligibility criteria
Inclusion criteria
- Patients between 18 and 60 years
- Signed informed consent
- Ulcerative colitis (UC) patients with active disease
- Crohn's disease (CD) patients with active disease
Exclusion criteria
- UC or CD patients in remission
- Patients between 18 and 60 years without informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele — Milan
Identifiers
NCT: NCT06580418 · TIME