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Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
St. Justine's Hospital
IWK Health Centre
Institut Rosell Lallemand
London Health Sciences Center, Children's Hospital
Information provided by (Responsible Party):
Sarah Williamson-Urquhart, University of Calgary
ClinicalTrials.gov Identifier:
NCT01853124
First received: May 9, 2013
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Gastroenteritis
Drug: Placebo
Drug: Lacidofil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Development of moderate to severe disease in the 2 weeks after the index visit [ Time Frame: Measured daily for 14 days ]

Secondary Outcome Measures:
  • Duration of Diarrhea [ Time Frame: Daily for 14 days ]
  • Duration of Vomiting [ Time Frame: Daily for 14 days ]
  • Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal, within two weeks [ Time Frame: Daily for 14 days ]
  • Work and Daycare Absenteeism [ Time Frame: Daily for 14 days ]

Other Outcome Measures:
  • Side Effect Profile [ Time Frame: Daily for 14 days ]
    Determine if short course probiotic administration to young children with acute gastroenteritis is associated with an increase in minor side effects

  • Mechanism of Action [ Time Frame: 28 Days ]
    Determine if probiotic administration increases fecal secretory IgA levels in children with acute gastroenteritis

  • Pathogen Load Quantification [ Time Frame: Determine if a 5-day probiotic treatment course administered to children with acute gastroenteritis results in pathogen-specific reductions in stool pathogen load ]
    5 Days


Enrollment: 886
Actual Study Start Date: November 2013
Estimated Study Completion Date: May 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacidofil
Lacidofil sachet containing active ingredients
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.
Placebo Comparator: Placebo
Placebo sachet containing inactive ingredients
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of diarrhea: defined as ≥ 3 watery stools in a 24-hour period
  • Duration of vomiting and/or diarrhea < 72 hours
  • Age 3 to < 48 months

Exclusion Criteria:

  • Presence of an indwelling vascular access line or structural heart disease
  • Taking immunosuppressive therapy, or known history of immunodeficiency
  • Hematochezia in the preceding 72 hours, underlying significant chronic gastrointestinal problem or inflammatory bowel disease
  • Family member with an indwelling vascular access line, on immunosuppressive therapy, or with a known immunodeficiency
  • Bilious vomiting
  • Probiotic use (supplement) in the preceding 2 weeks
  • Previously enrolled in this trial
  • Daily follow-up not possible
  • Allergy to Soy
  • Pre-existing (known) pancreatic dysfunction or insufficiency
  • Oral or Gastrointestinal surgery within preceding 7 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853124

Locations
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Children's Hospital, London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Sarah Williamson-Urquhart
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
St. Justine's Hospital
IWK Health Centre
Institut Rosell Lallemand
London Health Sciences Center, Children's Hospital
Investigators
Principal Investigator: Stephen Freedman, MD University of Calgary
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Williamson-Urquhart, Project Manager, University of Calgary
ClinicalTrials.gov Identifier: NCT01853124     History of Changes
Other Study ID Numbers: REB13-0045
Study First Received: May 9, 2013
Last Updated: April 18, 2017

Keywords provided by University of Calgary:
Diarrhea

Additional relevant MeSH terms:
Emergencies
Gastroenteritis
Disease Attributes
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 27, 2017