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

RecruitingNAAges 3 Years - 18 YearsAllMeyer Children's Hospital IRCCS
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Infliximab level analysis in biological samples
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Where

1 site
Meyer Children's Hospital, IRCCS - Gastroenterology and Nutrition Unit
Florence, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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