Lactobacillus GG in the Prevention of Antibiotic-Associated Diarrhea in the Pediatric Intensive Care Unit: A Prospective Randomized, Double-Blind Placebo Controlled Intervention.

Objective: The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the pediatric intensive care unit (PICU).

Methods: This was a prospective randomized, double-blind, placebo-controlled pilot trial in an academic PICU over 1 year. Patients ≤ 17 years who required antibiotic therapy ≥ 72 hours were randomly assigned to receive placebo or LGG. Exclusion criteria included antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and gastrointestinal (GI) disorders. LGG (30 × 10⁹ colony forming units) or a matching placebo capsule was administered twice daily for the duration of antibiotic therapy. Diarrhea was defined as 3 or more loose stools in 24 hours.

Results: A total of 36 patients were enrolled with 19 patients eligible for final analysis; 10 in the LGG group and 9 in the placebo group. Median age and weight of LGG vs placebo groups were 0.4 (0.17-1.42) vs 0.86 (1.21-10.92) years, p = 0.48, and 6 (3.4-9.9) vs 9.8 (3.71-39.6) kg, p = 0.31, respectively. Antibiotic associated diarrhea was experienced in 30% vs 55.5% of patients in the LGG groups vs placebo (p = 0.375), respectively. The median PICU length of stay for the patients with AAD was 6 days compared with 7.5 days in placebo group (p = 0.033). The RR ratio for AAD when using LGG was 0.59 (95% CI, 0.21-1.6). No adverse events were reported or attributed to LGG.

Conclusion: Results of this pilot study indicate that LGG is safe and could potentially reduce the incidence of AAD in the critically ill pediatric patients at this academic institution. Our findings suggest clinicians should consider the use of LGG in appropriate PICU patients.