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临床试验/NCT04165551
NCT04165551Unknown1 期

A Double-blind, Randomized, Controlled, Parallel Groups Study for the Evaluation of the Effects of the Consumption of Lactobacillus BSL_PS71 on the Load of Streptococcus Agalactiae on Vaginal Mucosa.

Biosearch S.A.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
60
试验地点
2
主要终点
Detection of Streptococus agalactiae in vaginal exudate

研究概览

简要总结

The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.

详细描述

Group B streptococci (Streptococcus agalactiae) are found in the vaginal microbiota in 10-30% of women without showing signs of infection. However, during delivery, it can be transmitted to the baby and, although in most cases it does not lead to disease, in a percentage of 5% of babies it causes serious infections that can trigger the death of the baby. In order to avoid this risk, a protocol of intra-partum preventive administration of antibiotics was implanted decades ago in women with a positive vaginal culture for this species in the weeks before birth. Taking into account the high percentage of women who show positive culture, this represents a high percentage of women who receive preventive antibiotic treatment with the consequences that this has for the mother's and baby's microbiota, as well as contributing to the generation of antibiotic resistance, a serious problem for today's society.

The fecal microbiota is considered a source of bacteria for the vaginal microbiota. In fact, women who present S. agalactiae in the vaginal microbiota also have it in stool. Given the demonstrated ability of Lactobacillus to control certain bacterial populations, the ability of a battery of Lactobacillus strains to inhibit the growth of S. agalactiae in the context of the fecal microbiota was analyzed. From these tests the strain Lactobacillus BSL_PS71 was selected for its antibacterial capacity against S. agalactiae.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Test positive for S. agalactiae in vaginal exudate
  • Accept freely to participate in the study and sign the informed consent document

排除标准

  • Consumption of probiotic supplements
  • Antibiotic use in the period of 2 weeks before the start of the study
  • Being pregnant or intending to get pregnant in the next 8 weeks
  • Being allergic to any group of antibiotics

结局指标

主要结局

Detection of Streptococus agalactiae in vaginal exudate

时间窗: 8 weeks

It will be determined the presence of S. agalactiae in vaginal exudate

次要结局

  • Cuantification of bacterial populations in vaginal exudate(8 weeks)

研究者

发起方
Biosearch S.A.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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