A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
研究概览
简要总结
Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Month 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.
排除标准
- •Age> 13 years old
- •Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
- •Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
- •Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
- •Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
- •Drug allergies, or allergic diseases..
- •Poor compliance with oral probiotics treatment.
研究组 & 干预措施
Probiotics
干预措施: Bifico (Drug)
结局指标
主要结局
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
时间窗: two years
次要结局
未报告次要终点
研究者
Jiexiong Feng
Chief of Pediatric Surgery
Tongji Hospital