Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

Summary

The objective of this study is to determine for previously healthy children who present to a Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of the digestive tract); if compared with placebo, the administration of a probiotic agent (Lacidofil) will result in a significantly lower proportion of children developing moderate to severe disease over the subsequent 2 weeks and will not be associated with a significantly greater occurrence of side effects.

Conditions

• Gastroenteritis

Interventions

DRUG

Placebo

All patients in this arm of the study will take 1 sachet containing inactive ingredients (maltodextrin, magnesium stearate, and ascorbic acid) twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Total of 2 sachets per day for 5 days.

DRUG

Lacidofil

All patients in this arm of the study will take 1 sachet twice daily for 5 days. Each sachet will contain a minimum of 4 billion colony-forming units (CFU) of Lactobacillus rhamnosus Rosell-11 (95%) and L. helveticus Rosell-52 (5%). The total weight of all ingredients is 1 gm. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Total daily dose = 8 billion CFU x 5 days.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Alberta Children's Hospital

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• Institut Rosell Lallemand

  collaborator INDUSTRY

• London Health Sciences Center, Children's Hospital

  collaborator UNKNOWN

• Dr. Stephen Freedman

  lead OTHER

Principal Investigators

• Stephen Freedman, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

48 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• Canada

Study Locations