The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are:

• Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU
• Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics

If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.

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

Design:

Prospective randomized, double-blind, placebo-controlled trial

Setting:

15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile, Alabama.

Patients:

Pediatric patients ≤ 17 years and required antibiotic therapy ≥ 72hrs were randomized to receive placebo or control (lactobacillus GG). Exclusion criteria included but was not limited to antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and GI disorders.

Interventions:

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.

Measurements:

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.

Inclusion Criteria:

• Admitted to PICU
• Requiring > 72 hrs of antibiotic therapy
• < 17 years
• Able to administer oral LGG or placebo

Exclusion Criteria:

• Antibiotics 48 hours prior to hospital admission
• Probiotic use within 7 days of admission
• Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
• Laxative therapy at time of admission or 48 hours prior to admission
• HIV with CD4 < 250
• Established immunologic deficiencies (ANC < 100)
• Chronic steroid therapy ( > 10 days)
• GI disorders including intussusception, lower bowel disease, bowel resection, irritable bowel syndrome, ulcerative colitis, or Crohn's disease
• Status post-surgical patients with antibiotic prophylaxis (< 72 hours duration)
• NPO

Only deidentified data

Matching placebo. Dispensed from pharmacy.