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NCT07209007: BURN-MICRO
Dynamics of Dysbiosis in the Skin and Gut Microbiome of Burn Patients
trial testing No Intervention: Observational Cohort in Burn Injuries in 600 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Cho Yoon soo |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 15 September 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- No Intervention: Observational Cohort — full drug profile →
Conditions studied
- Burn Injuries — all drugs for Burn Injuries →
- Skin Disease — all drugs for Skin Disease →
- Microbiome — all drugs for Microbiome →
- Microbiome Dysbiosis — all drugs for Microbiome Dysbiosis →
Sponsor
Cho Yoon soo
Who can join
Adults 19 to 65, any sex, with Burn Injuries or Skin Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07209007
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07209007 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cho Yoon soo
- Last refreshed: 6 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07209007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing