Neutrophil Oxidative Burst in Early and Late Onset Pediatric Inflammatory Bowel Disease
NCT ID: NCT06162936
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-11-01
2025-02-28
Brief Summary
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Aims To assess the clinical value of routinely measuring oxidative burst activity of granulocytes in pediatric patients diagnosed with very early onset IBD (VEO-IBD) and late onset IBD.
Objectives To investigate possible correlations between neutrophil function and IBD disease activity and to inquire the presence of genetic variants in those with low to absent oxidative burst. To identify the rate of monogenic VEO-IBD in our cohort.
Materials and Methods The proposal constitutes a collaborative effort among Romanian pediatric tertiary care centers to examine the value of assessing neutrophil function in all pediatric IBD patients. Children aged \<18 years diagnosed with Crohn's disease, ulcerative colitis or IBD-undetermined and age-matched healthy controls are recruited. A DHR flow cytometry assay is performed in included subjects and controls. Reduced or absent burst activity will lead to genetic testing in search of overt immunodeficiency or susceptibility variants. All VEO-IBD patients will have an immunological work-up in search of a primary immunodeficiency.
Expected Results We anticipate to include a number of 150 pediatric patients with IBD over 12 months from the three pediatric gastroenterology units in Bucharest, Romania. We expect to identify an overall diminished neutrophil function in IBD patients versus controls and possible variants in the NADPH-complex genes.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Inflammatory bowel disease patients
Pediatric patients (under 18 years of age) diagnosed with IBD
Phagoburst
The main objective is to perform oxidative burst activity in pediatric patients with a definitive diagnosis of IBD and compare them with healthy controls.
Lymphocytes subsets
To determine lymphocytes subsets in patients with suspicion of IEI
Genetic testing
Perform targeted genetic testing in those with reduced to absent oxidative activity in search of PIDs and susceptibility variants
Healthy controls
Healthy chidren (no chronic disease)
Phagoburst
The main objective is to perform oxidative burst activity in pediatric patients with a definitive diagnosis of IBD and compare them with healthy controls.
Interventions
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Phagoburst
The main objective is to perform oxidative burst activity in pediatric patients with a definitive diagnosis of IBD and compare them with healthy controls.
Lymphocytes subsets
To determine lymphocytes subsets in patients with suspicion of IEI
Genetic testing
Perform targeted genetic testing in those with reduced to absent oxidative activity in search of PIDs and susceptibility variants
Eligibility Criteria
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Inclusion Criteria
1. age under 18 years;
2. confirmed diagnosis of IBD fulfilling standard diagnosis criteria (clinical, radiological, endoscopical, histological features)
3. parental/guardian consent for study enrollment
Controls:
Healthy age-gender matched controls
Exclusion Criteria
2. Diagnosis of IBD uncertain
3. HIV/TB positive
18 Years
ALL
No
Sponsors
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Marie Curie Emergency Children's Hospital, Bucharest
UNKNOWN
Victor Gomoiu Children's Hospital, Bucharest
UNKNOWN
National Institute for Mother and Child Health Alessandrescu Rusescu
OTHER
Responsible Party
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Locations
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National Institute for Mother and Child Health Alessandrescu Rusescu
Bucharest, County, Romania
Countries
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Central Contacts
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Facility Contacts
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Alexis Virgil Cochino, MD, PhD
Role: primary
I
Role: backup
Other Identifiers
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IBD20232024
Identifier Type: -
Identifier Source: org_study_id