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Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance

16 april 2018 bijgewerkt door: Stephen Freedman, The Hospital for Sick Children

Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis

The objective of this study is to determine for previously healthy children, who present to an ED with acute gastroenteritis, if the probability of daycare absenteeism is significantly different in those who receive a probiotic agent compared to those who receive placebo.

Studie Overzicht

Gedetailleerde beschrijving

Gastroenteritis in children utilizes significant health care resources and has a significant impact on children, caregivers and society. In the United States, gastroenteritis accounts for more than 1.5 million outpatient visits and 200,000 hospitalizations per year. Data from British Columbia indicate that gastroenteritis annually accounts for 12 million missed workdays by adults and 10 million missed school days by children in this province alone. Canadian data, including the cost of work absenteeism, report the mean annual cost/gastroenteritis case to be $1,089.

Although medications have not routinely been recommended, acute gastroenteritis in children can result in significant morbidity. Thus, physicians and caregivers desire treatment options to reduce the burden of disease. Recently, ondansetron, an antiemetic agent has been found to be effective in pediatric gastroenteritis, and is now frequently employed to reduce vomiting. Probiotics agents may represent another valuable treatment option. Since the early 1990s, research has been conducted on the effects of probiotics, defined as viable microbial preparations that have a beneficial effect on the health and well being of the host.

A recent Cochrane Database systematic review recently concluded that "probiotics appear to be a useful adjunct to rehydration therapy in treating acute, infectious diarrhea." However, the review also concluded that more research is needed to determine which specific probiotic regimens should be employed in specific patient groups. The later statement is of particular importance in North America as probiotics are not a mainstay of clinical practice. While only 18% of Canadian physicians are aware of research on probiotics, 82% feel that more probiotic research is needed, and 76% feel there is a role for probiotics in their practice. This discrepancy likely is due to the absence of probiotic trials in North American patients and because the outcome measures evaluated often have had limited clinical applicability. Since most episodes of acute diarrhea require no specific treatment, cost-effectiveness analyses are also required before the widespread use of probiotics can be endorsed.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

132

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Ontario
      • Ottawa, Ontario, Canada
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada
        • Hospital Sainte Justine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

4 maanden tot 4 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Acute gastroenteritis as determined by the supervising physician.
  • Attend daycare
  • Presence of diarrhea.
  • Duration of vomiting or diarrhea less than 96 hours.
  • Age greater than 90 days
  • Age less than 48 months

Exclusion Criteria:

  • Presence of an indwelling vascular access line or congenital heart disease.
  • Taking immunosuppressive therapy or history of immunodeficiency (including all primary, secondary and acquired states)
  • Have recently had cardiac, oral or gastrointestinal surgery
  • Pancreatic dysfunction or bloody diarrhea
  • History of: hematochezia, underlying chronic gastrointestinal problem, short bowel syndrome or inflammatory bowel disease
  • Family member with an indwelling vascular access line, on immunosuppressive therapy or with a known immunodeficiency
  • Undergoing radiation therapy
  • Exclusively breastfed
  • Bilious or bloody vomitus
  • Previously enrolled in this trial
  • Inability to speak or read English

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1
Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet 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. Subjects in this arm will receive the high dose which will consist of 4 billion CFU (1 active sachet) PO BID (total daily dose = 8 billion CFU) x 5 days.
Experimenteel: 2
Each sachet will contain a minimum of 4 billion CFU/sachet. The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet 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. Subjects in this arm will receive the standard dose which will consist of 4 billion CFU (1 active sachet) PO QAM (total daily dose = 4 billion CFU) plus 1 placebo sachet PO QHS x 5 days.
Placebo-vergelijker: 3
The total weight of all ingredients is 1 gm. All patients in this arm of the study will take 1 sachet 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Tijdsspanne: 2 weeks
2 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Return visits for unscheduled care to a health care provider related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Tijdsspanne: 2 weeks
2 weeks
Intravenous rehydration
Tijdsspanne: 2 weeks
2 weeks
Duration of diarrhea
Tijdsspanne: Meaured by outcome
Meaured by outcome
Duration of vomiting
Tijdsspanne: Meaured by outcome
Meaured by outcome
Number of days the child does not go to daycare.
Tijdsspanne: Measured by outcome
Measured by outcome
Work absenteeism
Tijdsspanne: 2 weeks
2 weeks
Economic analysis
Tijdsspanne: 2 weeks
2 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Stephen Freedman, MD, The Hospital for Sick Children

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2009

Primaire voltooiing (Werkelijk)

1 september 2013

Studie voltooiing (Werkelijk)

1 maart 2014

Studieregistratiedata

Eerst ingediend

25 september 2008

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2008

Eerst geplaatst (Schatting)

26 september 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 april 2018

Laatste update ingediend die voldeed aan QC-criteria

16 april 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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