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Evaluation of the Efficacy of a Microbial Capsule Preparation for Restoring Gut Microbiome Balance in Burn Patients – A Pilot Study

Evaluation of the Efficacy of a Microbial Capsule Preparation for Restoring Gut Microbiome Balance in Burn Patients – A Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011499
Enrollment
8
Registered
2026-01-20
Start date
2026-01-13
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : The intervention used in this study is a freeze-dried, enteric-coated microbiome capsule (FMT Balance). This oral formulation is prepared from gut microorganisms derived from healthy donors a

Sponsors

Hallym University Medical Center-Hangang
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible participants are adult burn patients aged 19 to 65 years whose burn wounds have completely healed following sterile wound care or skin graft surgery at Hangang Sacred Heart Hospital. Participants must be able to understand the study procedures and provide written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1) Use of systemic or topical antibiotics or steroids within two weeks prior to enrollment 2) Pregnant or breastfeeding women, or women of childbearing potential 3) Presence of chronic conditions that may affect the skin or gut microbiome, such as diabetes or active dermatological diseases 4) Severe chronic systemic diseases, including serious hepatic, renal, or cardiac disorders 5) Any condition deemed inappropriate for study participation by the investigator

Design outcomes

Primary

MeasureTime frame
Change in gut microbiome composition before and after oral administration of the microbiome capsule (FMT Balance)

Secondary

MeasureTime frame
Changes in gut microbiome diversity indices (Shannon index and Simpson index)

Countries

Korea, Republic of

Contacts

Public ContactYeonGyun Jung

Hallym University Medical Center-Hangang

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

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026