Abstract

Introduction: Antibiotic associated diarrhea (AAD) is a common adverse effect in pediatric patients. Previous meta-analysis on probiotic use for AAD have reported that lactobacillus GG (LGG) has potential for more protective effects compared to other strains of probiotics. There is limited data on the use of LGG for the prophylaxis of AAD in the pediatric intensive care unit (PICU) where there is frequent use of broad-spectrum antibiotics. The objective of this study was to assess the efficacy of LGG to prevent AAD in the PICU. Methods: This prospective randomized, double-blind, placebo-controlled trial occurred in a 15-bed PICU. Inclusion criteria was age ≤ 17 years and required antibiotic therapy ≥ 72hrs. Exclusion criteria included but was not limited to antibiotics ≥ 48 hrs prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and GI disorders. Treatment with LGG (30 x 109 CFU) or a matching placebo capsule was administered twice daily, initiated within 24 hours of starting antibiotic therapy and continued for the duration of therapy. Diarrhea was defined as stools >200 mL or 200 g per day in a patient over 10 kg and > 20 mL/kg/day or > 20 g/kg/day in a patient < 10 kg or 3 or more loose stools in 24 hours. Patients that experienced diarrhea > 72 hours were crossed over. The primary outcome was the incidence of AAD in the LLG versus placebo groups. Potential adverse effects were monitored daily. Statistics were conducted with SPSS. Results: Thirty-one patients met the initial inclusion/exclusion criteria and were enrolled in the study. Nineteen patients were eligible for final analysis with 9 in the LGG group and 10 in the placebo group. Mean age was 0.96±1.3 and 4.7±6.4 years for the LGG and placebo groups, respectively. Mean weight was 6.95±4.21 and 22.76±29.38 kg for LGG and placebo groups, respectively. 30% vs 70% of patients experienced diarrhea in the LGG groups vs placebo (p=0.35). The median length of stay for the patients with AAD was 7.5 days compared to 6 days in placebo group (p=0.093). The odds ratio for AAD was 0.29 [95%CI 0.039-2.11]. No adverse events were reported or attributed to LGG. Conclusions: Results of this study indicate that LGG is safe and effective in reducing the incidence of AAD in the critically ill pediatric patients at our institution.

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