Assessing Neutrophil Function in Pediatric Inflammatory Bowel Disease

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

This study is testing how well the immune cells called neutrophils work in kids with inflammatory bowel disease to see if their function is linked to how active the disease is and to find out if there are any genetic factors involved.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: National Institute for Mother and Child Health Alessandrescu Rusescu (other)
• Locations: 1 site (Bucharest, County)
• Trial ID: NCT06162936 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the oxidative burst activity of neutrophils in pediatric patients diagnosed with very early onset inflammatory bowel disease (IBD) and late onset IBD. It seeks to establish correlations between neutrophil function and disease activity in IBD, as well as to identify genetic variants associated with low to absent oxidative burst. The study involves collaboration among several pediatric tertiary care centers in Romania and includes both patients with IBD and healthy controls for comparison.

Who should consider this trial

Good fit: Ideal candidates include children under 18 years with a confirmed diagnosis of inflammatory bowel disease.

Not a fit: Patients with IBD associated with a known monogenic defect or those with uncertain IBD diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of neutrophil function in pediatric IBD, potentially leading to improved diagnostic and therapeutic strategies.

How similar studies have performed: While the approach of assessing neutrophil function in IBD is promising, it is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

Subjects:

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:

1. IBD associated to an already defined monogenic defect
2. Diagnosis of IBD uncertain
3. HIV/TB positive

Where this trial is running

Bucharest, County

• National Institute for Mother and Child Health Alessandrescu Rusescu — Bucharest, County, Romania (RECRUITING)

Study contacts

• Study coordinator: Alexis Virgil Cochino, MD, PhD

Conditions: Chronic Granulomatous Disease, inflammatory bowel disease, chronic granulomatous disease, inborn errors of immunity