- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00760773
Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance
Impact of Emergency Department Probiotic Treatment of Diarrheal Illness on Daycare Attendance: Randomized Controlled Trial and Economic Analysis
Visão geral do estudo
Status
Condições
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
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
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
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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
Patrocinador
Investigadores
- Investigador principal: Stephen Freedman, MD, The Hospital for Sick Children
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1000012686
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .