Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study.
Mikio Nakajima, Morita Kojiro, Shotaro Aso...
https://pubmed.ncbi.nlm.nih.gov/31831039Actively Recruiting
Age: 18Years - 65Years
All Genders
ID07329595
Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Led by Tamas Vegh, MD · Updated on 2026-01-09
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Severe burn injuries can cause significant stress and damage to the intestines, leading to changes in the gut microbiome that may affect immune responses and recovery. This research aims to monitor how the gut microbiome changes over time after a severe burn injury and how these changes relate to inflammation, organ function, and patient outcomes such as infection rates and wound healing. Patients with severe burns involving more than 20% of their body or inhalation injuries are enrolled shortly after hospital admission. Fecal samples are collected initially and then once or twice a week for up to 12 weeks, following standard nutritional and intensive care protocols. The study analyzes the diversity and composition of gut bacteria using advanced DNA sequencing techniques to understand how the microbiome evolves during recovery. Participants undergo regular fecal sampling alongside weekly laboratory tests during their hospital stay. Researchers track changes in gut bacteria diversity and measure related inflammatory, endocrine, hematological, and immunological markers. Clinical outcomes such as survival, length of hospital stay, mechanical ventilation duration, infection rates, organ failure severity, and wound healing are also monitored throughout the study period.
CONDITIONS
Brief Title
Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged between 18 and 65 years
- Diagnosed with severe burn injury involving more than 20% of the total body surface area and/or inhalation injury
- Burn caused by scalding, flame, electrical, contact, or chemical exposure
- Hospital admission within 24 hours following injury
You will not qualify if you...
- Patients with inflammatory bowel diseases or malignant tumors
- Patients with a history of major stomach or intestinal surgery
- Patients with a pre-injury ECOG performance status of 4
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 12 weeks
Participants who have experienced severe burn injury are observed through regular fecal sample collection and laboratory investigations to assess changes in gut microbiome diversity and related clinical and immunological effects.
Weekly visits with one to two fecal sample collections per week and weekly laboratory investigations
Trial Site Locations
Total: 1 location
1
University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
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Research Team
L
Lenke Jenei Kluch, MD
E
Erzsebet Igbonu-Nagy, BSC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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