Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

Critical Illness Clinical Trial

Official title: Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Critical Illness
• Diarrhea

• NCT number: NCT06109740
• Study type: Interventional
• Source: University of South Alabama
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Completion date: November 2012