NCT06162936

Neutrophil Oxidative Burst in Early and Late Onset Pediatric Inflammatory Bowel Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: National Institute for Mother and Child Health Alessandrescu Rusescu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ABSTRACT Introduction Residual or absent oxidase function in peripheral neutrophils may point to an inborn defect of neutrophil function - chronic granulomatous disease (CGD) - whereas low to normal oxidative burst capacity has been linked to variants in various members of the NADPH-complex. 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.

Conditions

• Chronic Granulomatous Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Lymphocytes subsets	To determine lymphocytes subsets in patients with suspicion of IEI
DIAGNOSTIC_TEST	Genetic testing	Perform targeted genetic testing in those with reduced to absent oxidative activity in search of PIDs and susceptibility variants

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2023-12-08
• Last updated: 2023-12-08

Locations

1 site across 1 country: Romania