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Active, Not Recruiting

NCT Number: NCT07098377

Microbiota in Children With Severe 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 06132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasopharyngeal swab for biological sample analysis

Diagnostic Test

nasopharyngeal swab for biological sample analysis

Primary outcomes

  1. intestinal microbiota variation in burnt children

    Time frame: 21 days

    concentration of microbiota population in pediatric population severely burnt

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: MIBUS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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