Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Prevention of Hirschsprung's associated enterocolitis (HAEC)
研究概览
简要总结
Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.
详细描述
Randomised Controlled Study with two arms. All cases following up for post operative Hirschsprungs surgery are included in this study. First arm will receive a probiotics in the form of sachet for 6 months. Second arm will receive a multivitamin as placebo. Comparative analysis between the two groups for baseline and followup prevalence of Hirschsprungs associated enterocolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Probiotic Sachets
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hirschsprungs disease confirmed preoperative and postoperative specimen pathology
排除标准
- •Other cases of Enterocolitis and constipation
研究组 & 干预措施
Probiotics Group
Will receive Sachet-form probiotics
干预措施: Probiotics (Dietary Supplement)
Placebo Group
Will receive off-the-shelf oral multivitamin
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Prevention of Hirschsprung's associated enterocolitis (HAEC)
时间窗: 6 months
Absence of HAEC symptoms and signs; absence of fever, abdominal distension, loose stools (diarrhea) , bloody stools during the postoperative period for 6 months.
次要结局
- Improvement of stooling pattern of postoperative Hirschsprung's cases(6 months)
研究者
Mahmoud Elfiky, MD
Lecturer of Pediatric Surgery
Cairo University