MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease

NCT07470502 | Recruiting

• 1 other identifier: MICI-BIO
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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. During four routine clinical visits in the induction phase (standard or accelerated) and the first maintenance visit, two saliva samples (pre- and post-infusion) and one plasma sample (pre-infusion) will be collected. Plasma samples will be obtained from leftover blood collected during routine clinical practice, with no additional blood draws required. The induction regimen (standard or accelerated) will be determined by the treating physicians based on the patient's clinical and laboratory characteristics and will not be influenced by study participation. The study focuses on the first four infliximab infusions (three induction and one maintenance). Standard induction lasts 14 weeks (infusions at weeks 0, 2, 6, and 14), while accelerated induction lasts 8 weeks (infusions at weeks 0, 1, 4, and 8). The primary objective of the study is to compare infliximab levels measured in plasma with infliximab levels in saliva in a sample of 15 patients receiving the drug during the first four infusions after a diagnosis of IBD. The study is purely exploratory, and the collected data will not be used for diagnostic or therapeutic purposes.

Conditions

IBD (Inflammatory Bowel Disease)

Outcome Measures

Primary Outcomes (1)

• Comparison of Infliximab levels between saliva and plasma samples

  The primary objective of the study is to compare infliximab levels measured in plasma with infliximab levels measured in saliva in a sample of 15 patients receiving the drug during the first four infusions after a diagnosis of IBD. The study is purely exploratory, and the collected data will not be used for diagnostic or therapeutic purposes.

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Paediatric Patients with Inflammatory Bowel Disease

EXPERIMENTAL

Diagnostic Test: Infliximab level analysis in biological samples

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

Paediatric Patients with Inflammatory Bowel Disease

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 3 and 18 years
• diagnosis of Crohn's disease or ulcerative colitis
• starting biological therapy with infliximab;
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital, IRCCS - Gastroenterology and Nutrition Unit

Florence, Italy, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: February 13, 2025
• Primary Completion (Estimated): February 13, 2028
• Study Completion (Estimated): August 13, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)