Probiotics for the Prevention of Antibiotic-Associated Diarrhea — PAID  

Acute Diarrhea Clinical Trial

Official title: Probiotics in the Prevention of Antibiotic-Associated Diarrhea in Hospitalized Children: a Randomized Trial

Status Terminated

Clinical Trial Summary

In North America, one of the most common reasons for hospitalization in previously healthy children is for the treatment of infections with antibiotics. This study will determine if, in previously healthy children hospitalized and prescribed intravenous (IV) antibiotics, the co-administration of a probiotic milk product containing good bacteria, is safe and effective for reducing AAD, as compared to a placebo (identical appearing milk product). This will be a two-center, randomized, masked, placebo-controlled clinical trial. The results of this study will help inform clinicians and families on the use of probiotics in the prevention of AAD, a common side effect of antibiotic use among hospitalized children.

Clinical Trial Description

A two-centred randomized, multi-blind (i.e. patients, caregivers, data collectors, outcome assessors, data managers and analysts), placebo-controlled clinical trial intended to evaluate the efficacy and safety of Bio-K+ (Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2) in the prevention of AAD in hospitalized children 1 year to 17 years of age administered IV antibiotics. ;

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

• NCT number: NCT02817165
• Study type: Interventional
• Source: The Hospital for Sick Children
• Status: Terminated
• Phase: N/A
• Start date: November 2016
• Completion date: January 2018