title: Clinical safety and efficacy of probiotic administration following burn injury.
abstract: Provision of probiotics has been limited postburn by questionable potential for bacterial translocation and risk of infection in an immune-compromised population. The purpose of this study was to evaluate the safety of probiotic administration in acutely burned, pediatric patients. Subjects were randomized to receive probiotic (n = 10) vs placebo (n = 10) twice daily. The investigational product was initiated within 10 days of burn, and daily supplementation continued until wound closure. Nursing staff was provided education regarding optimal procedures to minimize potential for study product cross contamination. Clinical outcomes (infection, antibiotic, antifungal, and operative days, tolerance, and mortality) were recorded. Length of stay was modified for burn size. Student's t-test, χ test, and nonparametric Wilcoxon's rank-sum test were used for comparative analysis. No differences were noted (probiotic; placebo) for age (7.1 ± 2.2; 6.9 ± 1.7), burn size (38.0 ± 5.9; 45.5 ± 4.45), full thickness (24.6 ± 5.6; 32.1 ± 5.4), postburn day admit (0.8 ± 0.4; 1.1 ± 0.4), or inhalation injury (10%; 20%). Infection days, antibiotic use, constipation, and emesis were similar between groups. Trends toward increased antifungal and laxative use as well as diarrhea incidence were evident in the controls (P < .30). Flatulence was statistically higher with probiotics. The control group trended toward higher requirement for excision/graft procedure. Medical length of stay was not significantly different between groups; however, time required to complete wound healing was shortened with probiotics. This study documents safety and provides preliminary efficacy data relative to probiotic supplementation postburn.
authors.affiliation: From the *Department of Nutrition, Shriners Hospitals for Children, Cincinnati, Ohio; †Divison of Nutrition Therapy, Cincinnati Children's Hospital Medical Center, Ohio; ‡Department of Research, Shriners Hospitals for Children, Cincinnati, Ohio; §Department of Surgery, University of Cincinnati College of Medicine, Ohio; ‖Department of Nursing, Shriners Hospitals for Children, Cincinnati, Ohio; and ¶Department of Surgery, Shriners Hospitals for Children, Cincinnati, Ohio.
authors.forename: Theresa
authors.initials: T
authors.lastname: Mayes
authors.forename: Michele M
authors.initials: MM
authors.lastname: Gottschlich
authors.forename: Laura E
authors.initials: LE
authors.lastname: James
authors.forename: Chris
authors.initials: C
authors.lastname: Allgeier
authors.forename: Julie
authors.initials: J
authors.lastname: Weitz
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Kagan
mesh_terms: D000367:Age Factors; D002056:Burns / Q000473:pathology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D052201:Lacticaseibacillus rhamnosus; D007902:Length of Stay; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014945:Wound Healing