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Emergency Department Probiotic Treatment of Pediatric Gastroenteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01853124
Recruitment Status : Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : June 27, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: Placebo Drug: Lacidofil Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 886 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial
Actual Study Start Date : November 2013
Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

Secondary Outcome Measures :
  1. Duration of Diarrhea [ Time Frame: Daily for 14 days ]
  2. Duration of Vomiting [ Time Frame: Daily for 14 days ]
  3. 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 ]
  4. Work and Daycare Absenteeism [ Time Frame: Daily for 14 days ]

Other Outcome Measures:
  1. 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

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

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Sarah Williamson-Urquhart, University of Calgary:
Diarrhea

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