Effect of Saccharomyces Boulardii CNCM I-745 (Sb) on Bloody Diarrhea in Children. A Double Blind, Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Duration of bloody diarrhea
研究概览
简要总结
Acute diarrhea (AD) is one of the commonest illnesses in children. A particularly severe form of diarrhea is bloody diarrhea (BD).
Saccharomyces boulardii CNCM I-745 is a probiotic with demonstrated efficacy in children with acute diarrhea; however, evidence regarding its use in bloody diarrhea (BD) is lacking. This project aims to assess the efficacy and safety of Saccharomyces boulardii CNCM I-745 on bloody diarrhea in children.
The study objective are :
• To assess the efficacy of Sacharomyces Boulardi (SB) on acute bloody diarrhea in children aged 0 - 5 years. Indicators: duration of bloody diarrhea, daily frequency of stools with blood, daily frequency of total stools with or without blood during follow up.
• To assess the most frequent bacterial agents
• To assess the safety of the product. The study is a double blind, controlled trial (SB or placebo), with two arms parallel, randomized design, carried out on outpatient clinic because of acute bloody diarrhea.
详细描述
Patients with acute bloody diarrhea were prescribed randomly and blindly placebo or Saccharomyces boulardii 500 mg /day seven days (250 mg for children between 0.25 - 1.00 years),and were seen in outpatient clinics of three hospitals at days 1, 3, and 7. On day 14 they were contacted by telephone call. Parents registered daily number of stools, with or without diarrhea, and any new symptom appearing during follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all children between 0.25 and 5.99 years
- •attending emergency clinic because of acute diarrhea,
- •showing stools with presence of blood,
- •whose parents were adequately informed, and signed the corresponding consent
排除标准
- •diarrhea lasting more than 7 days at inclusion
- •presence of malnutrition and any other chronic or major disease,
- •previous or concomitant intake of steroids, or other immunosuppressive drugs,
- •immunocompromised
研究组 & 干预措施
Treatment Arm
干预措施: Saccharomyces boulardi (Sb) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of bloody diarrhea
时间窗: From baseline to end of follow-up (Day 14)
The number of days of bloody diarrhea between SB and placebo groups
Number of total stools per day
时间窗: From baseline to end of follow-up (Day 14)
Number of stools in children with or without blood in stools
Number of bloody stools per day
时间窗: From baseline to end of follow-up (Day 14)
Number of stools in children with blood in stools
次要结局
- Proportion of patients with positive stool culture, ELISA, PCR(At baseline)
- Safety adverse events(From baseline to end of follow-up (Day 14))