MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease
Not applicable · Testing Infliximab level analysis in biological samples · 1 site · Meyer Children's Hospital IRCCS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab level analysis in biological samples (a diagnostic test) as a way to diagnose or measure disease. Condition(s) listed: IBD (Inflammatory Bowel Disease).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 3 to 18
- Any sex
Some of the main requirements, copied from the record:
- Age between 3 and 18 years
- diagnosis of Crohn's disease or ulcerative colitis
- starting biological therapy with infliximab;
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 15 participants are expected to take part.
- Start date: 2025-02-13.
- Main results expected around 2028-02-13 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Comparison of Infliximab levels between saliva and plasma samples (From enrollment to the end of treatment at 8 weeks)
In the researchers’ words
This is a monocentric, non-profit prospective cohort study with longitudinal biological sampling. The study will include patients with IBD starting biological therapy with infliximab.
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 | Not applicable |
| Study type | Interventional |
| Conditions | IBD (Inflammatory Bowel Disease) |
| Lead sponsor | Meyer Children's Hospital IRCCS |
| Enrollment | 15 (estimated) |
| Start date | 2025-02-13 |
| Primary completion (est.) | 2028-02-13 |
| First posted | 2026-03-13 |
| Last updated | 2026-03-13 |
| Official title | Single-center Pilot Study for Proactive Monitoring of Infliximab in Patients With Chronic Inflammatory Bowel Disease Starting Biologic Therapy: Comparative Assessment of Plasma and Salivary Levels |
| ClinicalTrials.gov ID | NCT07470502 |
Interventions
- Infliximab level analysis in biological samples (Diagnostic Test)
For both patients receiving induction according to the standard of care and those receiving induction with an optimized regimen, Infliximab levels will be measured in saliva before and after infusion and in a plasma sample collected prior to drug infusion
Full eligibility criteria (from the record)
Inclusion Criteria: * Age between 3 and 18 years * diagnosis of Crohn's disease or ulcerative colitis * starting biological therapy with infliximab; * Signed informed consent. Exclusion Criteria: * Patients in whom the diagnosis of IBD has not been confirmed according to standardized endoscopic and histological criteria; * Patients who refuse to participate in the study.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Meyer Children's Hospital, IRCCS - Gastroenterology and Nutrition Unit | Florence, Italy | 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.