Inflammatory Bowel Diseases
Conditions
Keywords
IBD
Brief summary
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
OTHERAdditional 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.
Sponsors
IRCCS San Raffaele
Inotrem
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist | 20 months | Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound | 26 months | Measurement of pro-inflammatory cytokine concentrations (pg/ml) |
| Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound | 26 months | RNAseq analysis |
Countries
Italy
Outcome results
None listed