Dynamics of Dysbiosis in the Skin and Gut Microbiome of Burn Patients

NCT07209007 | Recruiting

• 2 other identifiers: HG 2025-023HG2025-023
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Burn injuries are known to induce systemic physiological and immune responses that may lead to widespread microbial dysbiosis (microbial imbalance) beyond the injured site. However, the dynamics of microbial community changes in both burned and non-burned skin, as well as the gut, remain poorly understood. In this study, a total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. For burn patients, skin swabs from burned scars and matched non-burned skin, stool samples, and physiological skin measurements will be collected at multiple time points (baseline, 3 months, 6 months, 12 months, and 24 months). Healthy controls will provide skin and stool samples at baseline only. Microbial profiling will be performed using 16S ribosomal RNA (rRNA) gene sequencing, and functional prediction will be analyzed using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Physiological skin-barrier measurements, including transepidermal water loss (TEWL), hydration, pH, erythema, and elasticity, will be assessed using standardized instruments. Blood biomarkers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), will also be measured. The findings of this study will improve our understanding of burn-related microbial dysbiosis, provide insights into microbiome-driven skin-barrier recovery, and inform potential therapeutic strategies for long-term burn care.

Conditions

Burn Injuries; Skin Disease; Microbiome; Microbiome Dysbiosis

Keywords

Burn Injury; Skin Microbiome; Gut Microbiome; Dysbiosis; 16S rRNA Sequencing

Outcome Measures

Primary Outcomes (2)

• Change in Skin Microbiome Diversity

  Alpha and beta diversity indices of the skin microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline. Unit of Measure: Shannon diversity index (unitless)

  Baseline, 3, 6, 12, and 24 months after burn injury

• Change in Gut Microbiome Diversity

  Alpha and beta diversity indices of the gut microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline. Unit of Measure: Shannon diversity index (unitless)

  Baseline, 3, 6, 12, and 24 months after burn injury

Secondary Outcomes (6)

• Functional Prediction of Microbiome

  Baseline, 3, 6, 12, 24 months

• Transepidermal Water Loss (TEWL)

  Baseline, 3, 6, 12, 24 months

• Skin Hydration

  Baseline, 3, 6, 12, and 24 months after burn injury

• Skin Elasticity

  Baseline, 3, 6, 12, and 24 months after burn injury

• Serum C-Reactive Protein (CRP) Concentration

  Baseline, 3, 6, 12, 24 months

Study Arms (1)

Burn Patients Cohort

This cohort includes 600 adult burn patients who experienced partial- or full-thickness burns. Participants will provide skin swabs, stool samples, blood samples, and skin physiological measurements at baseline, 3, 6, 12, and 24 months after injury. The primary objective is to investigate longitudinal changes in the skin and gut microbiome and their association with skin barrier recovery and systemic inflammation.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

This is an observational cohort study with no interventions administered. Skin swabs, stool samples, blood samples, and skin physiological measurements will be collected at baseline, 3, 6, 12, and 24 months after burn injury to investigate longitudinal changes in the skin and gut microbiome.

Burn Patients Cohort

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll 600 adult burn patients aged 19 to 65 years who have experienced partial- or full-thickness burns. Participants will be recruited from the Burn Center at Hallym University Hangang Sacred Heart Hospital. All participants must provide written informed consent.

You may qualify if:

• Adults aged 19 to 65 years
• Patients with partial- or full-thickness burns whose wounds have completely healed following debridement, grafting, or conservative treatment
• Ability to understand study objectives and provide written informed consent

You may not qualify if:

• Use of systemic or topical antibiotics, probiotics, steroids, or immunosuppressants within 2 weeks prior to sample collection
• Pregnancy or breastfeeding
• Chronic skin diseases (e.g., psoriasis, eczema) or systemic illnesses affecting the skin microbiome
• Active infections at the sampling site
• Any medical condition judged by the investigator to make participation inappropriate

Sponsors & Collaborators

• Cho Yoon soo: lead

Study Sites (1)

Hallym University Hangang Sacred Heart Hospital

Seoul, 07247, South Korea

RECRUITING

Related Publications (13)

• Jung Y, Cui HS, Joo SY, Lee EK, Seo CH, Cho YS. Sex differences in the skin microbiome of burn scars. Wound Repair Regen. 2023 Jul-Aug;31(4):547-558. doi: 10.1111/wrr.13088. Epub 2023 Jun 24.

  PMID: 37129034 BACKGROUND

• Jung Y, Cui HS, Lee EK, Joo SY, Seo CH, Cho YS. Effects of Factors Influencing Scar Formation on the Scar Microbiome in Patients with Burns. Int J Mol Sci. 2023 Nov 6;24(21):15991. doi: 10.3390/ijms242115991.

  PMID: 37958976 BACKGROUND

• Ersanli C, Tzora A, Voidarou CC, Skoufos S, Zeugolis DI, Skoufos I. Biodiversity of Skin Microbiota as an Important Biomarker for Wound Healing. Biology (Basel). 2023 Aug 30;12(9):1187. doi: 10.3390/biology12091187.

  PMID: 37759587 BACKGROUND

• Corcione S, Lupia T, De Rosa FG; Host and Microbiota Interaction Study Group (ESGHAMI) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Microbiome in the setting of burn patients: implications for infections and clinical outcomes. Burns Trauma. 2020 Aug 14;8:tkaa033. doi: 10.1093/burnst/tkaa033. eCollection 2020.

  PMID: 32821744 BACKGROUND

• Nakai K, Kubota Y, Soma GI, Kohchi C. The Effect of Lipopolysaccharide-containing Moisturizing Cream on Skin Care in Patients With Mild Atopic Dermatitis. In Vivo. 2019 Jan-Feb;33(1):109-114. doi: 10.21873/invivo.11446.

  PMID: 30587610 BACKGROUND

• Ogawa R, Akaishi S. Endothelial dysfunction may play a key role in keloid and hypertrophic scar pathogenesis - Keloids and hypertrophic scars may be vascular disorders. Med Hypotheses. 2016 Nov;96:51-60. doi: 10.1016/j.mehy.2016.09.024. Epub 2016 Sep 28.

  PMID: 27959277 BACKGROUND

• Gimblet C, Meisel JS, Loesche MA, Cole SD, Horwinski J, Novais FO, Misic AM, Bradley CW, Beiting DP, Rankin SC, Carvalho LP, Carvalho EM, Scott P, Grice EA. Cutaneous Leishmaniasis Induces a Transmissible Dysbiotic Skin Microbiota that Promotes Skin Inflammation. Cell Host Microbe. 2017 Jul 12;22(1):13-24.e4. doi: 10.1016/j.chom.2017.06.006. Epub 2017 Jun 29.

  PMID: 28669672 BACKGROUND

• Liu SH, Huang YC, Chen LY, Yu SC, Yu HY, Chuang SS. The skin microbiome of wound scars and unaffected skin in patients with moderate to severe burns in the subacute phase. Wound Repair Regen. 2018 Mar;26(2):182-191. doi: 10.1111/wrr.12632. Epub 2018 May 21.

  PMID: 29663582 BACKGROUND

• Baldwin HE, Bhatia ND, Friedman A, Eng RM, Seite S. The Role of Cutaneous Microbiota Harmony in Maintaining a Functional Skin Barrier. J Drugs Dermatol. 2017 Jan 1;16(1):12-18.

  PMID: 28095528 BACKGROUND

• Lehtimaki J, Karkman A, Laatikainen T, Paalanen L, von Hertzen L, Haahtela T, Hanski I, Ruokolainen L. Patterns in the skin microbiota differ in children and teenagers between rural and urban environments. Sci Rep. 2017 Mar 31;7:45651. doi: 10.1038/srep45651.

  PMID: 28361981 BACKGROUND

• Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.

  PMID: 19478181 BACKGROUND

• Rogers MB, Firek B, Shi M, Yeh A, Brower-Sinning R, Aveson V, Kohl BL, Fabio A, Carcillo JA, Morowitz MJ. Disruption of the microbiota across multiple body sites in critically ill children. Microbiome. 2016 Dec 29;4(1):66. doi: 10.1186/s40168-016-0211-0.

  PMID: 28034303 BACKGROUND

• Alekseyenko AV, Perez-Perez GI, De Souza A, Strober B, Gao Z, Bihan M, Li K, Methe BA, Blaser MJ. Community differentiation of the cutaneous microbiota in psoriasis. Microbiome. 2013 Dec 23;1(1):31. doi: 10.1186/2049-2618-1-31.

  PMID: 24451201 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Skin swabs, stool samples, and blood samples will be collected from burn patients at multiple time points (baseline, 3, 6, 12, and 24 months). Skin swabs will be taken from burned scars and matched non-burned skin areas. Stool samples will be used for gut microbiome profiling, and blood samples will be used for measuring systemic inflammatory biomarkers. All specimens will be stored under controlled conditions for future microbiome and biomarker analyses, and DNA will be extracted from skin and stool samples for 16S rRNA sequencing.

MeSH Terms

Conditions

Burns; Skin Diseases; Dysbiosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yoon Soo Cho, MD, PhD

CONTACT

+82-2-2639-5730; yschorm@hallym.ac.kr

YeonGyun Jung, PhD

CONTACT

+82-2-2639-5730; jyg1076@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 6, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)