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临床试验/NCT04778722
NCT04778722招募中不适用

Development of Microbiome Vaginae After Use of Oral Probiotics in First the Trimester of Pregnancy. A Prospective Pilot Study

Associate Prof. Ljubomir Petricevic MD2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
2
主要终点
CST

研究概览

简要总结

Change of Vaginal microbiome in first trimester pregnant women after oral intake of Probiotic preparation with 4 lactobacilli strains

详细描述

Although the research of the vaginal microbiome is taking faster pace in recent years than it was the case before, there is still lack of information, about its composition, how and when it changes and how that can affect processes in the female body.

During pregnancy, the microbiome physiologically gets increasingly stable. Diversity of bacteria decreases, which is the sign of a healthy microbiome, and Lactobacillus species increase their already pre-existing dominance. Acidic metabolites of those bacteria maintain the low pH and low diversity in vagina.

If the dominance of lactobacilli is not as large as it should be, the risk of preterm birth increases significantly. Low relative abundance of Lactobacillus species, especially Lactobacillus crispatus (marker of the healthy microbiome) and lactobacillus metabolites as well as high vaginal microbial diversity are most significantly connected with preterm birth.

Despite such a high relevance of vaginal microbiome for a healthy pregnancy, and for women's health in general, there's an insufficient proof that the intake of oral probiotics can change it. The aim of our study is to see if the intake of patented dietary supplement, containing four Lactobacillus strains can change the relative abundance of different bacteria in the vaginal microbiome. This could lay ground for further research in this area and even create new therapeutic approaches in the future.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Pregnant women aged between 18 and 45
  • infection screening during a prenatal consultation between 10+0 (10 weeks plus 0 days) and 16+0 (16 weeks plus 0 days) gestational weeks
  • Singleton pregnancy

排除标准

  • Vaginal infections such as Bacterial vaginosis, candida vaginitis, trichomoniasis, mycoplasma, gonococcal infection
  • Antibiotic therapy in the last 4 weeks
  • Probiotic therapy in the last 4 weeks
  • Operation on gastrointestinal tract
  • Diarrhoea, obstipation
  • Vaginal bleeding
  • Patients with hormone disorders of any kind
  • Other chronic diseases (Diabetes, Autoimmune diseases etc.)
  • Gestational diabetes

结局指标

主要结局

CST

时间窗: 14 Days

change of vaginal microbiome after probiotic intake

次要结局

  • Lactobacilli Change(14 Days)

研究者

发起方
Associate Prof. Ljubomir Petricevic MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Associate Prof. Ljubomir Petricevic MD

principal investigator

Medical University of Vienna

研究点 (2)

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