NCT06109740

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of South Alabama · Academic / Other
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Critical Illness
• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lactobacillus GG	probiotic

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-10-01
• Completion: 2012-11-01
• First posted: 2023-10-31
• Last updated: 2023-10-31