Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
Observational · No treatment assigned · 1 site · Inotrem
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 60
- Any sex
Some of the main requirements, copied from the record:
- Patients between 18 and 60 years
- Signed informed consent
- Ulcerative colitis (UC) patients with active disease
Plus 1 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2023-01-31.
- Main results expected around 2025-03-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist (20 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Inotrem |
| Collaborators | IRCCS San Raffaele |
| Enrollment | 40 (estimated) |
| Start date | 2023-01-31 |
| Primary completion (est.) | 2025-03-31 |
| First posted | 2024-08-30 |
| Last updated | 2025-02-27 |
| Official title | Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model |
| ClinicalTrials.gov ID | NCT06580418 |
Interventions
- Additional biopsies and blood samples (Other)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele | Milan | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.