ACTRN12615000923561已完成4 期
Evaluation of the probiotic Lactobacillus Fermentum CECT5716 for the prevention of mastitis in breastfeeding women: a randomised controlled trial
Perinatal Research Group, Kolling Institute, University of Sydney0 个研究点目标入组 600 人开始时间: 2015年9月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Pregnant women at least 18 years of age at 37 weeks gestation or later with a singleton pregnancy will be invited to participate in the trial. They will currently not be taking commercial probiotics containing lactobacillus fermentum; and will own a smartphone. Their intention at the time of consent will be to breastfeed their baby.
排除标准
- •Women with a history of Raynaud syndrome will not be eligible to participate in the trial. Any delivery/breast complication rendering the infant unable to breastfeed will be excluded. Women unable to speak/understand English will not be consented.
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