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Probiotics for the Prevention of Antibiotic-Associated Diarrhea

NCT02817165 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

  • Acute Diarrhea

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Patricia Parkin, MD · The Hospital for Sick Children

  • Gordon Guyatt, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-10-31
Completion
2018-01-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02817165 on ClinicalTrials.gov