Infliximab level monitoring in children with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a monocentric, non-profit prospective cohort at Meyer Children's Hospital in Florence enrolling patients aged 3–18 with confirmed Crohn's disease or ulcerative colitis who are starting infliximab. During the first four infliximab infusions (three induction and one maintenance), two saliva samples (pre- and post-infusion) and one plasma sample (pre-infusion) will be collected at four routine clinical visits, using leftover blood from routine care so no extra blood draws are required. The induction regimen (standard or accelerated) is chosen by the treating physician and will not be influenced by study participation. Collected samples will be analyzed for infliximab levels to explore pharmacokinetic patterns during induction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Meyer Children's Hospital, IRCCS - Gastroenterology and Nutrition Unit
  Florence, Italy, Italy Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Maternal and infant microbiome links to infant gut inflammation and pregnancy outcomes in people with IBD

  This project will see if mothers' microbiomes, diets, and breastmilk are linked to infant gut inflammation (measured by fecal calprotectin) in pregnant people with and without IBD.

  Recruiting University of British Columbia · Vancouver, British Columbia and 1 other locations · NCT07385807

• Infliximab plus the Crohn's Disease Exclusion Diet for children with Crohn's disease

  This will test whether starting a Crohn's Disease Exclusion Diet at the same time as infliximab helps children with moderate-to-severe Crohn's disease get better and stay in remission.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT07314606

• SMART-IBD app for teens with inflammatory bowel disease

  This will test whether the SMART-IBD smartphone app helps adolescents ages 13–17 with IBD take their medicines and manage symptoms better than completing daily diaries alone.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07195123

• Single-dose MT-201 with Infliximab in healthy adults

  This early phase study tests a single dose of MT-201 given with infliximab in healthy adults to see if it is safe and how the body handles it.

  Recruiting Phase 1 Mirador Therapeutics, Inc. · San Diego, California · NCT07776782

• Melatonin to improve sleep quality in adults with inflammatory bowel disease in remission

  This study tests whether melatonin can improve sleep quality in adults with IBD who are in clinical remission.

  Recruiting Phase 4 Mahidol University · Bangkok Noi, Bangkok · NCT07737665

• Infliximab plus prednisone vs prednisone alone for ICI-associated AKI

  This study tests whether adding infliximab to prednisone helps adults with kidney injury caused by cancer immunotherapy recover kidney function faster than standard prednisone alone.

  Recruiting at 2 sites Phase 4 Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT07683975

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.