NCT02817165

Probiotics for the Prevention of Antibiotic-Associated Diarrhea

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic (BioK+)	Probiotic (BioK+) with 3 stains of Lactobacillus
OTHER	Placebo	Strawberry flavored tub of milk, identical (taste, color, odor) to the active Bio-K+ treatment.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-10-01
• Completion: 2018-01-01
• First posted: 2016-06-29
• Last updated: 2018-04-18

Locations

2 sites across 1 country: Canada