Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
研究概览
简要总结
In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.
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, Investigator)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal pregnancy
- •Healthy women
- •Lactational mastitis in, at least, a previous lactation period
- •No symptomatic vaginal infections
排除标准
- •Any kind of health problems related to pregnancy
- •Symptomatic vaginal infections
- •Allergy to cow's milk protein
- •Intolerance to lactose
- •Antibiotic treatment
研究组 & 干预措施
Probiotic
Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)
干预措施: Lactobacillus salivarius PS2 (Biological)
Placebo
Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)
干预措施: Excipient (milk powder) (Biological)
结局指标
主要结局
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
时间窗: Weekly during the first 6 months after birth
次要结局
- Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab(At weeks 30, 35, 40 of pregnancy)
研究者
Juan M. Rodríguez
Professor, PhD
Universidad Complutense de Madrid