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

16 de abril de 2018 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

132

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

4 meses a 4 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Experimental: 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.
Comparador de Placebo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Proportion of children missing a day of daycare related to vomiting, diarrhea, dehydration, fever, or fluid refusal.
Prazo: 2 weeks
2 weeks

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Stephen Freedman, MD, The Hospital for Sick Children

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2009

Conclusão Primária (Real)

1 de setembro de 2013

Conclusão do estudo (Real)

1 de março de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

25 de setembro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de setembro de 2008

Primeira postagem (Estimativa)

26 de setembro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de abril de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de abril de 2018

Última verificação

1 de abril de 2018

Mais Informações

Termos relacionados a este estudo

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