Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Staphylococcal and/or streptococcal count in milk
研究概览
简要总结
A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women. On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by midwifes on days 0, 7, 14 and 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mastitis
- •Staphylococcal and/or streptococcal count higher than 3000 colony-forming units per ml of milk
- •Milk leukocyte count higher 6 log10/mL
- •Must be able to provide a milk sample without the aid of a milk pump
排除标准
- •Mammary abscesses
- •Any kind of parallel disease
研究组 & 干预措施
Probiotic 1
Women receiving Lactobacillus salivarius HN6
干预措施: Lactobacillus salivarius HN6 (Biological)
Probiotic 2
Women receiving Lactobacillus reuteri CR20
干预措施: Lactobacillus reuteri CR20 (Biological)
Probiotic 3
Women receiving Lactobacillus fermentum LC40
干预措施: Lactobacillus fermentum LC40 (Biological)
beta-lactam
The evolution of the women ascribed to the other three arms will be compared with that of 100 women suffering lactational mastitis that will follow a conventional antibiotic treatment as prescribed by the pediatrician/gynecologist
干预措施: Beta-lactam antibiotic (Drug)
结局指标
主要结局
Staphylococcal and/or streptococcal count in milk
时间窗: 0 and 28 days
次要结局
- Assessment of local and systemic symptoms associated to mastitis(days 0, 7, 14 and 28)