Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
研究概览
简要总结
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight infants < 1500 gr
- •Gestational age < 32 weeks
排除标准
- •Genetic anomalies
- •Short bowel syndrome
- •Not willing to participate
- •Allergy to Lactobacillus reuteri components
研究组 & 干预措施
Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months
干预措施: Lactobacillus reuteri (Dietary Supplement)
Nystatin
50000 unit/3 times a day
干预措施: Nystatin (Drug)
结局指标
主要结局
Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
时间窗: up to 6 months
Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.
次要结局
- Effect of Lactobacillus reuteri on feeding intolerance(up to 6 months)
- Effect of Lactobacillus reuteri on sepsis(up to 6 months)
- Effect of Lactobacillus reuteri on length of hospital stay(up to 6 months)
- Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants(up to 6 months)
研究者
Mehmet Yekta
Principal Investigator
Zekai Tahir Burak Women's Health Research and Education Hospital