Microbiota in Children With Severe Burn Injury (MIBUS)

Gut, Nasopharyngeal, and Skin Microbiota in Children With Severe Burn Injury: the Role in Infectious Complications in Burn Injury

The research protocol consists of taking aliquots of biological specimens from skin swabs, nasopharyngeal swabs, and fecal swabs. the samples will be taken at time 0 of admission to the Pediatric ICU, one week after admission, and two weeks after admission to compare the bacterial populations present at the different sampling sites.

Study Overview

• Status: Active, not recruiting
• Conditions: Burn
• Intervention / Treatment: Diagnostic test: nasopharyngeal swab for biological sample analysis

Detailed Description

Pediatric burns (0-14 years) make up 26% of emergency room admissions for burns, with 73% of cases in children under 5 years old. The most common burns are thermal from boiling liquids, followed by open flames and fireworks. Severe burns (>20% of body surface area) provoke a systemic inflammatory response that causes hypovolemia, tissue hypoperfusion, and metabolic stress, establishing a vicious cycle that is difficult to break.

Burn trauma can also compromise the intestinal barrier, composed of cellular junctions (tight junctions), damage to which increases intestinal permeability. This promotes the passage of luminal contents into the systemic circulation, aggravating the immune and inflammatory response. Gut dysfunction is often accompanied by dysbiosis of the microbiota, with risk of bacterial translocation to sterile organs (liver, lungs, brain), contributing to systemic complications in critically ill patients.

The study hypothesizes that burn trauma increases intestinal permeability, promoting bacterial translocation and anticipating infectious complications. Analyzing microbial populations at exposed sites (skin, gut, BAL) during trauma and pediatric ICU care may help to better understand the origin of septic complications.

• Study Type: Observational
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 06132
    • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children suffering from burn trauma with signs and symptoms of burns, without antibiotic therapy in the previous 48 hours and without major congenital malformations. Authorization for data processing and participation in the study by the patient or their legal guardians is also considered.

Description

Inclusion Criteria:

• signs and/or symptoms of burn injury

Exclusion Criteria:

• major congenital malformation
• Antibiotic treatment 48 hours prior to admission
• failure to provide informed consent to participate in the protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
burns affected	Diagnostic test: nasopharyngeal swab for biological sample analysis; nasopharyngeal swab for biological sample analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intestinal microbiota variation in burnt children	concentration of microbiota population in pediatric population severely burnt	21 days

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Orazio Genovese, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: July 25, 2025
• First Posted (Actual): August 1, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sepsis; burns; microbiota
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 7327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: results microbiota variation in severely burnt children
• IPD Sharing Time Frame: two years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No