• Clinical Evaluation of the Safety of Postbiotic Spray for the Treatment of Burn Wounds and Infections
  • Mohammad Abootaleb,1 Narjes Mohammadi Bandaria,2 mohammad karimli,3 Mohammadreza Mobayen,4,*
    1. Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran
    2. Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran
    3. Department of Biology, Faculty of Basic Science, Damghan Branch, Islamic Azad University, Damghan, Iran cHealth Information Management
    4. Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran


  • Introduction: Burn wounds and bacterial infections caused by Pseudomonas aeruginosa and its biofilm present significant treatment challenges in burn hospitals, necessitating appropriate therapeutic methods. Traditional treatment approaches often depend on antibiotics, which carry the risk of resistance and side effects. Metabolites produced by probiotics, with their antimicrobial and immune-enhancing effects, have been regarded as a potentially suitable alternative to antibiotics in preclinical studies. This study aims to assess the safety of a topical postbiotic spray for improving the healing of burn wounds and preventing infections in human participants
  • Methods: This experimental study was a randomized, double-blind, controlled clinical trial conducted on healthy volunteers aged 18 to 65 years, aimed at assessing the safety of the postbiotic spray. The study has been registered with the ethics committee of Guilan University of Medical Sciences under the number IR.gums.REC.1401.608 and in the Iranian Registry of Clinical Trials under the number IRCT20210524051384N9. For this purpose, participants were randomly divided into two groups: Group One (intervention group) received a postbiotic spray containing a mixture of metabolites produced by probiotic strains, while Group Two (control group) received a placebo spray containing saline. Both groups used the spray for 28 days, once every 12 hours, at a specific distance from the designated area, with a dose of 100 to 300 micrograms per spray. The safety of this spray during the trial was monitored through specialized medical examinations using a standardized checklist, including demographic information, and potential local and systemic side effects, and was documented via digital imaging.
  • Results: Volunteers aged 18 to 65 years were selected for the safety assessment of the study. Local and systemic adverse events were monitored and evaluated using a standard checklist at five stages (days 1, 7, 14, 21, and 28). The findings revealed that the probiotic spray being investigated had no significant negative effects. After conducting this study, we look forward to positive results from further research on topical probiotic solutions. Probiotics may prove to be a safer and more effective alternative to antibiotics, with fewer adverse effects.
  • Conclusion: The findings of this clinical trial indicate that the topical probiotic spray is devoid of clinical local and systemic adverse effects, and considering the antibacterial properties of probiotics, it may effectively enhance the healing process of burn wounds and prevent bacterial infections in patients.
  • Keywords: Probiotics; safety, clinical trial, wounds and injuries, drug side effects